Designations List
DESIGNATION IS A STATUS THAT MAKES A PHARMACEUTICAL SPONSOR ELIGIBLE FOR INCENTIVES TO SUPPORT DRUG APPROVAL. DESIGNATION DOES NOT ALLOW THE DRUG TO BE MARKETED (SOLD, PROMOTED, OR ADVERTISED). IT IS ILLEGAL TO MARKET THESE PRODUCTS UNTIL THEY ARE APPROVED OR CONDITIONALLY APPROVED. (See the “Status” column of this table for approval information).
| No. | Sponsor Name & Address | Established & Proprietary Name |
Dosage Form | Species | Intended Use (Indication + species) |
Designation | Modified | Status |
|---|---|---|---|---|---|---|---|---|
| 1 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Catfish | For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri | 8/18/2005 | NADA 141-246 approved 10/24/2005 Exclusive marketing rights expired 10/24/2012 |
|
| 2 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared warmwater finfish | For the control of mortality in freshwater-reared warmwater finfish due to streptococcal septicemia associated with Streptococcus iniae | 9/19/2005 | 5/28/2010 | NADA 141-246 approved 4/4/2012 Exclusive marketing rights expired 4/4/2019 |
| 3 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum | 9/19/2005 | 9/6/2006 | NADA 141-246 approved 3/19/2007 Exclusive marketing rights expired 3/19/2014 |
| 4 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater reared salmonids due to columnaris disease associated with Flavobacterium columnare | 9/19/2005 | 9/6/2006 | Designation terminated at sponsor's request 9/30/2011 |
| 5 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater reared salmonids due to furunculosis associated with Aeromonas salmonicida | 9/19/2005 | 9/6/2006 | NADA 141-246 approved 10/26/2007 Exclusive marketing rights expired 10/26/2014 |
| 6 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater reared salmonids due to enteric redmouth disease associated with Yersinia ruckeri | 9/19/2005 | 9/6/2006 | Designation terminated 2/2/2018 |
| 7 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Tilapia | For the control of mortality in tilapia due to streptococcal septicemia associated with Streptococcus iniae | 9/19/2005 | 1/9/2007 | Designation terminated at sponsor's request 5/28/2010 |
| 8 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared warmwater finfish | For the control of mortality in freshwater-reared warmwater finfish due to hemorrhagic septicemia associated with Aeromonas hydrophila | 9/19/2005 | 5/28/2010 | |
| 9 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Tilapia | For the control of mortality in tilapia due to edwardsiellosis associated with Edwardsiella tarda | 9/19/2005 | 1/9/2007 | Designation terminated 10/20/2017 |
| 10 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Seawater-reared salmonids | For the control of mortality in seawater-reared salmonids due to furunculosis associated with Aeromonas salmonicida | 9/19/2005 | 1/11/2007 | Designation terminated at sponsor's request 7/25/2013 |
| 11 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Seawater-reared salmonids | For the control of mortality in seawater-reared salmonids due to cold-water vibriosis associated with Vibrio salmonicida | 9/19/2005 | 1/11/2007 | Designation terminated at sponsor's request 7/25/2013 |
| 12 | Boehringer Ingelheim Vetmedica, Inc. 2621 North Belt Highway St. Joseph, MO 64506 |
Moxidectin CYDECTIN |
Oral | Sheep | For the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep: Haemonchus contortus, Teladorsagia circumcincta, Teladorsagia trifurcata, Trichostrongylus axei, Trichostrongylus colubriformis, Trichostrongylus vitrinus, Cooperia curticei, Cooperia oncophora, Oesophagostomum columbianum, Oesophagostomum venulosum, Nematodirus battus, Nematodirus filicollis, Nematordirus spathige | 10/14/2005 | NADA 141-247 approved 11/30/2005 Exclusive marketing rights expired 11/30/2012 |
|
| 13 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared finfish eggs | For the control of mortality in freshwater-reared finfish eggs due to saprolegniasis | 12/1/2005 | NADA 141-255 approved 1/11/2007 Exclusive marketing rights expired 1/11/2014 |
|
| 14 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum | 12/1/2005 | NADA 141-255 approved 1/11/2007 Exclusive marketing rights expired 1/11/2014 |
|
| 15 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared coolwater finfish and channel catfish | For the control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare | 12/1/2005 | NADA 141-255 approved 1/11/2007 Exclusive marketing rights expired 1/11/2014 |
|
| 16 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Progesterone EAZI-BREED CIDR Sheep Insert |
Intravaginal | Sheep | For the induction of estrus in ewes (sheep) during seasonal anestrous | 12/14/2005 | NADA 141-302 approved 10/1/2009 Exclusive marketing rights expired 10/1/2016 |
|
| 17 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared finfish | For the control of mortality in freshwater-reared finfish (except freshwater-reared coolwater finfish and warmwater finfish) due to external columnaris disease associated with Flavobacterium columnare | 12/20/2005 | 5/22/2015 | Designation terminated at sponsor's request 4/21/2021 |
| 18 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared finfish | For the control of mortality in freshwater‐reared coldwater finfish (all life stages) due to saprolegniasis associated with fungi in the family Saprolegniaceae | 12/20/2005 | 5/22/2015 1/25/2019 |
NADA 141-255 approved 7/26/2019 |
| 19 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Calcein SE-MARK |
Immersion | Freshwater-reared finfish fry & fingerlings | For the skeletal marking of freshwater-reared finfish fry and fingerlings | 1/26/2006 | Designation terminated at sponsor's request 8/25/2011 | |
| 20 | Rangen, Inc. 115 13th Avenue South Buhl, ID 83316 |
17a-methyl testosterone MASCULINIZING FEED FOR TILAPIA |
Type C medicated feed | Tilapia | For the masculinization of female early life-stage tilapia | 1/27/2006 | Designation terminated at sponsor's request 11/26/2018 | |
| 21 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Isoeugenol AQUI-S |
Immersion | Freshwater-reared finfish | To sedate freshwater-reared finfish to handleable | 2/6/2006 | Designation terminated at sponsor's request 9/13/2018 | |
| 22 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Isoeugenol AQUI-S |
Immersion | Freshwater-reared finfish | To anesthetize freshwater-reared finfish | 2/6/2006 | Designation terminated at sponsor's request 9/13/2018 | |
| 23 | GB Research, Inc. (US agent Kent SeaTech Corp.) 11125 Flintkote Avenue, Suite J San Diego, CA 92121 |
Amoxicillin trihydrate USP powder |
Type A medicated article | Hybrid Striped Bass & Tilapia | For the control of mortality in hybrid striped bass and tilapia due to steptococcosis associated with Streptococcus iniae | 2/14/2006 | Designation terminated at sponsor's request 12/30/2008 | |
| 24 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Catfish | For the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare | 3/13/2006 | Application 141-259 Conditionally approved 4/13/2007 NADA 141-246 approved 4/4/2012 Exclusive marketing rights expired 4/13/2014 |
|
| 25 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Isoeugenol AQUI-S |
Immersion | Seawater-reared salmonids | To sedate seawater-reared salmonids to handleable | 3/21/2006 | Designation terminated at sponsor's request 9/13/2018 | |
| 26 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Isoeugenol AQUI-S |
Immersion | Seawater-reared salmonids | To anesthetize seawater-reared salmonids | 3/21/2006 | Designation terminated at sponsor's request 9/13/2018 | |
| 27 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Albendazole VALBAZEN |
Oral | Goats | For the treatment of adult liver flukes (Fasciola hepatica) in nonlactating goats | 3/24/2006 | NADA 110-048 approved 1/24/2008 Exclusive marketing rights expired 1/24/2015 |
|
| 28 | Phibro Animal Health Glenpointe Centre East, 3rd Fl. 300 Frank W. Burr Boulevard Suite 21 Teaneck, NJ 07666 |
Oxytetracycline TERRAMYCIN 200 for Fish |
Type A medicated article | Freshwater-reared finfish (except steelhead trout) | For the control of mortality due to columnaris disease associated with Flavobacterium columnare in catfish and freshwater-reared salmonids (except Oncorhynchus mykiss) | 4/27/2006 4/15/2021 |
3/20/2008 | |
| 29 | Phibro Animal Health Glenpointe Centre East, 3rd Fl. 300 Frank W. Burr Boulevard Suite 21 Teaneck, NJ 07666 |
Oxytetracycline TERRAMYCIN 200 for Fish |
Type A medicated article | Steelhead trout | For the control of mortality in Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare | 4/27/2006 | 3/20/2008 | NADA 038-439 approved 7/6/2008 Exclusive marketing rights expired 7/6/2015 |
| 30 | Phibro Animal Health Glenpointe Centre East, 3rd Fl. 300 Frank W. Burr Boulevard Suite 21 Teaneck, NJ 07666 |
Oxytetracycline TERRAMYCIN 200 for Fish |
Type A medicated article | Coolwater and warmwater-reared finfish (except salmonids and catfish) | For the control of mortality in coolwater and warmwater-reared finfish (except salmonids and catfish) due to bacterial hemorrhagic septicemia associated with Aeromonas hydrophila | 4/27/2006 | ||
| 31 | Phibro Animal Health Glenpointe Centre East, 3rd Fl. 300 Frank W. Burr Boulevard Suite 21 Teaneck, NJ 07666 |
Oxytetracycline TERRAMYCIN 200 for Fish |
Type A medicated article | Penaeid shrimp | For the control of mortality in penaeid shrimp due to necrotizing hepatopancreatitis | 4/27/2006 | ||
| 32 | Phibro Animal Health Glenpointe Centre East, 3rd Fl. 300 Frank W. Burr Boulevard Suite 21 Teaneck, NJ 07666 |
Oxytetracycline TERRAMYCIN 200 for Fish |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum | 4/27/2006 | NADA 038-439 approved 7/6/2008 Exclusive marketing rights expired 7/6/2015 |
|
| 33 | Axcentive SARL Chemin de Champouse 13320 Bouc Bel Air France |
Chloramine-T HALAMID AQUA |
Immersion | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp | 6/13/2006 | NADA 141-423 approved 4/30/2014 Exclusive marketing rights expired 4/30/2021 |
|
| 34 | Axcentive SARL Chemin de Champouse 13320 Bouc Bel Air France |
Chloramine-T HALAMID AQUA |
Immersion | Walleye | For the control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare | 6/13/2006 | NADA 141-423 approved 4/30/2014 Exclusive marketing rights expired 4/30/2021 |
|
| 35 | Axcentive SARL Chemin de Champouse 13320 Bouc Bel Air France |
Chloramine-T HALAMID AQUA |
Immersion | Freshwater-reared finfish (except walleye) | For the control of mortality in all freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare | 6/13/2006 | 1/24/2014 | NADA 141-423 approved 4/30/2014 Exclusive marketing rights expired 4/30/2021 |
| 36 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
sGnRHa & domperidone OVAPRIM |
Injectable | Ornamental fish | For the induction of spawning in ornamental fish | 7/27/2006 | Designation terminated at sponsor's request 12/13/2012 | |
| 37 | Carus Chemical Co. 315 Fifth Street P.O. Box 599 Peru, IL 61354 |
Potassium permanganate CAIROX |
Immersion | Freshwater-reared finfish | For the control of mortality in freshwater-reared finfish due to external columnaris disease associated with Flavobacterium columnare | 9/12/2006 | Designation terminated at sponsor's request 12/22/2011 | |
| 38 | Carus Chemical Co. 315 Fifth Street P.O. Box 599 Peru, IL 61354 |
Potassium permanganate CAIROX |
Immersion | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchophilum | 9/12/2006 | Designation terminated at sponsor's request 12/22/2011 | |
| 39 | Carus Chemical Co. 315 Fifth Street P.O. Box 599 Peru, IL 61354 |
Potassium permanganate CAIROX |
Immersion | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum | 9/12/2006 | Designation terminated at sponsor's request 12/22/2011 | |
| 40 | Axcentive SARL Chemin de Champouse 13320 Bouc Bel Air France |
Chloramine-T HALAMID AQUA |
Immersion | Freshwater-reared finfish (except freshwater-reared salmonids) | For the control of mortality in freshwater-reared finfish (except freshwater-reared salmonids) due to bacterial gill disease associated with Flavobacterium spp | 9/15/2006 | Designation terminated at sponsor's request 1/24/2014 | |
| 41 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Progesterone EAZI-BREED CIDR Goat Insert |
Intravaginal | Goats | For synchronization of estrus in meat and dairy goats during the breeding season | 10/3/2006 | ||
| 42 | Chem One Ltd 14140 Westfair East Drive Houston, TX 77041 |
Copper Sulfate TRIANGLE BRAND COPPER SULFATE |
Immersion | Channel catfish | For the treatment of ichthyophthiriasis (Ichthyophthirius multifilis) on channel catfish cultured in earthen ponds | 10/30/2006 | Designation terminated 12/27/2017 | |
| 43 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Metomidate AQUACALM |
Immersion | Ornamental fish | For use as a sedative during transport of ornamental (non-food) finfish | 11/13/2006 | Designation terminated at sponsor's request 5/14/2013 | |
| 44 | Bimeda, A Division of Cross Vetpharm Group, Ltd. 2836 Dolliver Park Avenue Lehigh, IA 50557 |
Erythromycin thiocyanate AQUAMYCIN 100 |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to bacterial kidney disease associated with Renibacterium salmoninarum | 1/4/2007 | Designation terminated 8/12/2015 | |
| 45 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
salmon Gonadotropin Releasing Hormone analog OVAPLANT |
Implantation | Salmonids | For the induction of spawning in mature salmonids | 5/25/2007 | Designation terminated at sponsor's request 9/30/2015. | |
| 46 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Oxytetracycline HCl TERRAMYCIN 343 |
Immersion | Freshwater-reared coolwater and warmwater finfish fry and fingerlings | For control of mortality in fry and fingerlings of all coolwater and warmwater species of freshwater-reared finfish due to external columnaris disease associated with Flavobacterium columnare | 6/7/2007 | Designation terminated at sponsor's request 5/5/2011 | |
| 47 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Oxytetracycline HCl TERRAMYCIN 343 |
Immersion | Freshwater-reared coolwater and warmwater finfish fry and fingerlings | For control of mortality in fry and fingerlings of all coolwater and warmwater species of freshwater-reared finfish due to systemic columnaris disease associated with Flavobacterium columnare | 6/7/2007 | Designation terminated at sponsor's request 5/5/2011 | |
| 48 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Oxytetracycline HCl TERRAMYCIN 343 |
Immersion | Freshwater-reared coolwater and warmwater finfish fry and fingerlings | For control of mortality in fry and fingerlings of all coolwater and warmwater species of freshwater-reared finfish due to bacterial gill disease associated with Flavobacterium branchophilum | 6/7/2007 | Designation terminated at sponsor's request 5/5/2011 | |
| 49 | Dechra Veterinary Products 7015 College Boulevard Suite 525 Overland Park, KS 66211 |
Trilostane VETORYL |
Oral | Dogs | For treatment of hyper- adrenocorticism due to adrenocortical tumor in dogs | 8/21/2007 | NADA 141-291 approved 12/05/2008 Exclusive marketing rights expired 12/5/2015 |
|
| 50 | PetMedicus Laboratories, Inc. 101 South Main Avenue Fourth Floor Sioux Falls, SD 57104 |
Ondansetron VML-028 |
Oral | Dogs | For prevention of cisplatin-induced emesis in dogs | 8/24/2007 | Designation terminated 2/17/2011 | |
| 51 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Formalin PARASITE-S |
Immersion | Freshwater-reared finfish | For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae | 12/19/2007 | NADA 140-989 approved 4/11/2019 |
|
| 52 | Acrivet, Inc. 9071 South 1300 West Suite 102 Salt Lake City, UT 84088 |
Deep Scleral Lamellar Cyclosporine Implant | Implantation | Horses | For the management of severe equine recurrent uveitis (ERU) that is refractive to standard treatment and in the absence of blindness, cataract, glaucoma, or active inflammation in the affected eye or eyes | 12/16/2007 | Designation terminated at sponsor's request 10/28/2008 | |
| 53 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Tricaine methanesulfonate TRICAINE-S |
Immersion | Finfish | For the euthanasia of finfish not intended for food | 1/4/2008 | Designation terminated at sponsor's request 8/25/2011 | |
| 54 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Emamectin benzoate SLICE |
Type A medicated article | Salmonids | For the control of Salmincola californiensis on freshwater-reared Oncorhynchus mykiss | 2/22/2008 | 6/25/2010 3/11/2019 |
|
| 55 | PetMedicus Laboratories, Inc. 101 South Main Avenue Fourth Floor Sioux Falls, SD 57104 |
Piroxicam VML-030 |
Oral | Dogs | For palliation of clinical signs associated with transitional cell carcinoma (TCC) of the bladder in dogs | 9/19/2008 | Designation terminated 2/17/2011 | |
| 56 | AB Science 3, Avenue George V 75008 Paris, France |
Masitinib KINAVET CA-1 |
Oral | Dogs | For treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids | 10/9/2008 | 12/23/2011 | Application 141-308 Conditional approval expired 12/15/2015 Designation expired 12/15/2017 |
| 57 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared coolwater finfish | To sedate all freshwater-reared coolwater finfish to handleable condition | 12/30/2008 | ||
| 58 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared coolwater finfish | To lightly sedate all freshwater-reared coolwater finfish for transport purposes | 12/30/2008 | ||
| 59 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared salmonid finfish | To sedate all freshwater-reared salmonid finfish to handleable condition | 12/30/2008 | ||
| 60 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared salmonid finfish | To lightly sedate all freshwater-reared salmonid finfish for transport purposes | 12/30/2008 | ||
| 61 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared warmwater finfish, except freshwater-reared channel catfish | To sedate all freshwater-reared warmwater finfish, except freshwater-reared channel catfish, to handleable condition | 12/30/2008 | ||
| 62 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared warmwater finfish, except freshwater-reared channel catfish | To lightly sedate all freshwater-reared warmwater finfish, except freshwater-reared channel catfish, for transport purposes | 12/30/2008 | ||
| 63 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Saltwater-reared salmonid finfish | To sedate all saltwater-reared salmonid finfish to handleable condition | 12/30/2008 | ||
| 64 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Saltwater-reared salmonid finfish | To lightly sedate all saltwater-reared salmonid finfish for transport purposes | 12/30/2008 | ||
| 65 | Oasmia Pharmaceutical AB Vallongatan 1 SE-752 28 Uppsala Sweden |
Paclitaxel PACCAL VET |
Injectable | Dogs | For the treatment of nonresectable Grade II and III mast cell tumors in dogs that have not received previous therapy except corticosteroids | 4/6/2009 | Designation terminated 8/13/2018 | |
| 66 | Royer Biomedical Inc. 4580 Mack Ave., Suite E Frederick, MD 21703 |
Cisplatin MIII Cisplatin Beads |
Implantation | Horses | For the local treatment of equine sarcoids up to 3 cm in diameter, excluding lesions that are flat, or those that are located within 1.5 cm of a vital anatomical structure, such as the eye, urethra, or rectum | 5/1/2009 | ||
| 67 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Dibotermin alfa TRUSCIENT |
Implantation | Dogs | For the treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction | 5/15/2009 | 5/3/2011 | Designation terminated at sponsor's request 12/18/2014 |
| 68 | Frontier Scientific, Inc. P.O. Box 31 Logan, UT 84323 |
Benzocaine BENZOAK |
Immersion | Freshwater-reared finfish | For anesthesia of freshwater-reared finfish | 5/27/2009 | Designation terminated at sponsor's request 12/10/2012 | |
| 69 | Frontier Scientific, Inc. P.O. Box 31 Logan, UT 84323 |
Benzocaine BENZOAK |
Immersion | Freshwater-reared finfish | For sedation during transport of freshwater-reared finfish | 5/27/2009 | Designation terminated at sponsor's request 12/10/2012 | |
| 70 | Frontier Scientific, Inc. P.O. Box 31 Logan, UT 84323 |
Benzocaine BENZOAK |
Immersion | Freshwater-reared finfish | For use as a short-term sedative for the purposes of handling freshwater-reared finfish | 5/27/2009 | Designation terminated at sponsor's request 12/10/2012 | |
| 71 | ACD Pharmaceuticals AS Serviceboks 9-6025 Alesund, Norway |
Benzocaine BENZOAK |
Immersion | Saltwater-reared salmonid finfish | For sedation to handleable condition for all saltwater-reared salmonids | 6/22/2009 | Designation terminated at sponsor's request 2/5/2015 | |
| 72 | ACD Pharmaceuticals AS Serviceboks 9-6025 Alesund, Norway |
Benzocaine BENZOAK |
Immersion | Saltwater-reared salmonid finfish | For sedation during transport of all saltwater-reared salmonids | 6/22/2009 | Designation terminated at sponsor's request 6/25/2013 | |
| 73 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared channel catfish | To lightly sedate all freshwater-reared channel catfish for transport purposes | 7/6/2009 | ||
| 74 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Freshwater-reared channel catfish | To sedate all freshwater-reared channel catfish to handleable condition | 7/6/2009 | ||
| 75 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared salmonids | For the control of Ichthyophthirius multifiliis on freshwater-reared salmonids | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 76 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared coolwater finfish | For the control of Ichthyophthirius multifiliis on freshwater-reared coolwater finfish species | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 77 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared warmwater finfish | For the control of Ichthyophthirius multifiliis on freshwater-reared warmwater finfish species | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 78 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared salmonids | For the control of Ichthyobodo necator on freshwater-reared salmonids | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 79 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared coolwater finfish | For the control of Ichthyobodo necator on freshwater-reared coolwater finfish species | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 80 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared warmwater finfish | For the control of Ichthyobodo necator on freshwater-reared warmwater finfish species | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 81 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared salmonids | For the treatment and control of Gyrodactylus spp. in freshwater-reared salmonids | 9/17/2009 | 5/22/2015 | NADA 141-255 approved 7/26/2019 |
| 82 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared coolwater finfish | For the control of Gyrodactylus spp. on freshwater-reared coolwater finfish species | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 83 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared warmwater finfish | For the control of Gyrodactylus spp. on freshwater-reared warmwater finfish species | 9/17/2009 | Designation terminated at sponsor's request 1/14/2021 | |
| 84 | Beeologics, Inc. Office 1306 13th Floor, Tower II Al Fattan Currency House DIFC Dubai United Arab Emirates |
Israeli Acute Paralysis Virus specific dsRNA REMEBEE |
Oral | Honey bees | For the control of mortality associated with Israeli Acute Paralysis Virus (IAPV) in honey bees | 11/2/2009 | Designation terminated at sponsor's request 7/3/2014 |
|
| 85 | Frontier Scientific, Inc. P.O. Box 31 Logan, UT 84323 |
Lauryl methyl pyrifrin AQUAFRIN |
Immersion | Freshwater-reared salmonids | For control of mortality in freshwater-reared salmonids due to saprolegniasis associated with fungi in the family Saprolegniaceae | 3/19/2010 | Designation terminated at sponsor's request 8/9/2012 | |
| 86 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared finfish, except catfish | For the control of mortality due to columnaris disease associated with Flavobacterium columnare in freshwater-reared finfish, except catfish | 5/28/2010 | 9/30/2011 | NADA 141-246 approved 4/4/2012 |
| 87 | Chem One Ltd 14140 Westfair East Drive Houston, TX 77041 |
Copper Sulfate TRIANGLE BRAND COPPER SULFATE |
Immersion | Channel catfish eggs | For the control of mortality in channel catfish eggs due to saprolegniasis associated with fungi of the family Saprolegniaceae | 7/15/2010 | Designation terminated 12/27/2017 | |
| 88 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Tulathromycin DRAXXIN Injectable Solution |
Injectable | Non-lactating goats | For the treatment of respiratory disease associated with Mannheimia haemolytica in non-lactating goats | 8/11/2010 | Designation terminated at sponsor's request 11/19/2015. | |
| 89 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Tulathromycin DRAXXIN Injectable Solution |
Injectable | Sheep | For the treatment of respiratory disease associated with Mannheimia haemolytica in sheep | 11/8/2010 | Designation terminated at sponsor's request 6/12/2014 |
|
| 90 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Lincomycin Hydrochloride LINCOMIX Soluble Powder |
Oral | Honey Bees | For the control of American Foulbrood (Paenibacillus larvae) in honey bees | 11/26/2010 | NADA 111-636 approved 3/27/2012 |
|
| 91 | Tocagen, Inc. 3030 Bunker Hill Street #230 San Diego, CA 92109 |
Replication competent amphotropic murine leukemia virus with a cytosine deaminase gene (TOCA 511) and oral flucytosine (5-FC) | Injectable (intracranial) TOCA 511 followed by oral flucytosine three weeks later |
Dogs | For the treatment of primary malignant brain tumors in dogs | 1/26/2011 | Designation terminated at sponsor's request 9/25/2017 | |
| 92 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Fenbendazole SAFE-GUARD |
Type A medicated article | Pheasants | For the removal and control of adult Syngamus trachea (gapeworm) in pheasants | 2/1/2011 | ||
| 93 | Aqua Pharma U.S., Inc. 12015 115th Avenue NE Suite 120 Kirkland, WA 98034 |
Hydrogen peroxide 50% INTEROX PARAMOVE 50 |
Immersion | Saltwater-reared Atlantic salmon | For treatment of Lepeophtheirus salmonis sea lice on saltwater-reared Atlantic salmon (Salmo salar) | 4/26/2011 | ||
| 94 | Oasmia Pharmaceutical AB Vallongatan 1 SE-752 28 Uppsala Sweden |
Paclitaxel PACCAL VET |
Injectable | Dogs | For the treatment of resectable and nonresectable squamous cell carcinoma in dogs that have not received previous chemotherapy or radiotherapy | 5/19/2011 | 9/20/2013 | Application 141-422 Conditional approval withdrawn 2/8/2017 |
| 95 | Postive Feed, Ltd. P. O. Box 1049 Sealy, TX 77474 |
Ivermectin | Type C medicated feed | Beef cattle | For the control of cattle fever ticks (Rhipicephalus microplus and R. annulatus) in beef cattle as part of the US Cattle Fever Tick Eradication Program | 5/20/2011 | Designation terminated 6/15/2018 | |
| 96 | Nuovo Biologics LLC 10650 SW 137th St. Miami, FL 33176 |
Alpha-neurotoxoid PANAVIRA | Injectable | Dogs | For the treatment of local disease in stage II and III oral malignant melanoma in dogs | 7/27/2011 | ||
| 97 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Freshwater-reared salmonids | For the control of mortality in freshwater-reared salmonids due to bacterial kidney disease (BKD) associated with Renibacterium salmoninarum | 8/3/2011 | Designation terminated at sponsor's request 1/30/2019 | |
| 98 | ECO Animal Health 344 Nassau Street Princeton, NJ 08540 |
Tylvalosin AIVLOSIN |
Oral | Pheasants | For the control of respiratory infections associated with Mycoplasma gallisepticum in pheasants | 9/28/2011 | Designation terminated at sponsor's request 8/10/2015 | |
| 99 | FVG Ltd. 22 Carsegate Road Inverness, Scotland IV3 8EX |
Azamethiphos SALMOSAN VET |
Immersion | Saltwater-reared Atlantic salmon | For the treatment and control of adult and pre-adult Lepeophtheirus salmonis sea lice on saltwater-reared Atlantic salmon (Salmo salar) | 9/30/2011 | Designation terminated at sponsor's request 10/7/2020 | |
| 100 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Luteinizing Hormone-Releasing Hormone analog (LHRHa) | Injectable | Channel catfish | For use as a spawning aid for female channel catfish (Ictalurus punctatus) | 10/6/2011 | ||
| 101 | Eagle Aquaculture, Inc. 300 North Dean Road Suite 5 Auburn, AL 36830 |
Luteinizing Hormone-Releasing Hormone analog (LHRHa) | Implantation | Channel catfish | For use as a spawning aid for female channel catfish (Ictalurus punctatus) | 10/6/2011 | Designation terminated at sponsor's request 6/11/2015 | |
| 102 | Oasmia Pharmaceutical AB Vallongatan 1 SE-752 28 Uppsala Sweden |
Paclitaxel PACCAL VET |
Injectable | Dogs | For the treatment of nonresectable stage III, IV or V mammary carcinoma in dogs that have not received previous chemotherapy or radiotherapy | 12/22/2011 | 9/10/2013 | Application 141-422 Conditional approval withdrawn 2/8/2017 |
| 103 | Pathogenes, Inc. P.O. Box 970 Fairfield, FL 32634 |
Decoquinate/Levamisole OROGIN |
Oral | Horses | For the treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona in horses | 5/7/2012 | Designation terminated at sponsor's request 7/11/2019 | |
| 104 | Oasmia Pharmaceutical AB Vallongatan 1 SE-752 28 Uppsala Sweden |
Doxorubicin DOXOPHOS VET |
Injectable | Dogs | For the treatment of lymphoma in dogs | 6/27/2012 | Designation terminated 11/29/2018 | |
| 105 | Elanco US Inc. 2500 Innovation Way Greenfield, IN 46140 |
Monepantel ZOLVIX |
Oral | Sheep | For the treatment and control of gastrointestinal nematodes in sheep at the adult stage, including Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus colubriformis, Trichostrongylus axei, and Cooperia curticei | 7/3/2012 | Designation terminated at sponsor's request 1/18/2018 | |
| 106 | Elanco US Inc. 2500 Innovation Way Greenfield, IN 46140 |
Monepantel ZOLVIX |
Oral | Goats | For the treatment and control of gastrointestinal nematodes in goats at the adult stage, including Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus colubriformis, Trichostrongylus axei, and Cooperia curticei | 7/3/2012 | Designation terminated at sponsor's request 4/23/2014 | |
| 107 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Gonadotropin Releasing Factor Analog-Diphtheria Toxoid conjugate IMPROVEST |
Injectable | Swine | For the immunological castration and reduction of male aggressive and sexual behavior in cull adult breeding boars intended for slaughter | 8/14/2012 | Designation terminated at sponsor's request 10/6/2016 | |
| 108 | Elanco US Inc. 2500 Innovation Way Greenfield, IN 46140 |
Imidacloprid/Moxidectin ADVANTAGE MULTI for Cats |
Topical | Ferrets | For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis; ADVANTAGE MULTI for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets | 8/29/2012 |
NADA 141-254 approved 10/31/2013 Exclusive marketing rights expired 10/31/2020 |
|
| 109 |
Therapeutic Vision, Inc. |
2-methyl sorbinil KINOSTAT |
Ophthalmic | Dogs | For the prevention of diabetic cataracts in dogs with diabetes mellitus | 9/10/2012 | ||
| 110 | Zoetis Inc. 333 Portage Street Kalamazoo, MI 49007 |
Lasalocid sodium AVATEC |
Type A medicated article | Pheasants | For the control of coccidiosis associated with Eimeria spp. in pheasants | 10/25/2012 | Designation terminated at sponsor's request 7/16/2020 | |
| 111 | Hybrid Catfish Company 1233 Montgomery Drive Inverness, MS 38753 |
Catfish pituitary | Injectable | Channel catfish | For use as a spawning aid for female channel catfish | 11/8/2012 | Designation terminated at sponsor's request 2/20/2018 | |
| 112 | VetDC, Inc. 320 E. Vine Drive, Suite 101 Fort Collins, CO 80524 |
Rabacfosadine succinate TANOVEA |
Injectable | Dogs | For the treatment of lymphoma in dogs | 11/20/2012 | 6/18/2013 | Application 141-475 Conditionally approved 12/29/2016 |
| 113 | Pathogenes, Inc. P.O. Box 970 Fairfield, FL 32634 |
Levamisole HCl NEUROQUEL |
Oral | Horses | For the control of residual or recurrent clinical signs due to inflammation associated with Equine Protozoal Myeloencephalitis (EPM) following anti-protozoal therapy | 3/5/2013 | ||
| 114 | Anivive Lifesciences, Inc. 3250 Airflite Way Long Beach, CA 90807 |
Verdinexor LAVERDIA |
Oral | Dogs | For the treatment of lymphoma in dogs | 4/3/2013 | Application 141-526 Conditionally approved 1/11/2021 | |
| 115 | Pharmgate LLC 1800 Sir Tyler Drive Wilmington, NC 28405 |
Oxytetracycline HCl PENNOX 343 |
Immersion | Ornamental finfish | For the control of mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater-reared ornamental finfish | 7/3/2013 | Designation terminated 12/14/2018 | |
| 116 | Pharmgate LLC 1800 Sir Tyler Drive Wilmington, NC 28405 |
Oxytetracycline HCl PENNOX 343 |
Immersion | Freshwater-reared salmonid fry and fingerlings | For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonid fry and fingerlings | 7/3/2013 | Designation terminated 12/14/2018 | |
| 117 | Pharmgate LLC 1800 Sir Tyler Drive Wilmington, NC 28405 |
Oxytetracycline HCl PENNOX 343 |
Immersion | Fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish | For the control of mortality due to bacterial gill disease associated with Flavobacterium spp. in fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish | 7/8/2013 | Designation terminated 12/14/2018 | |
| 118 | Pharmgate LLC 1800 Sir Tyler Drive Wilmington, NC 28405 |
Oxytetracycline HCl PENNOX 343 |
Immersion | Fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish | For the control of mortality due to external columnaris disease associated with Flavobacterium columnare in fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish | 7/8/2013 | Designation terminated 12/14/2018 | |
| 119 | Torquin, LLC 508 Kodiak Trail Cedar Park, TX 78613 |
RC-2B (geroxane) |
Injectable | Dogs | For the treatment of lymphoma in dogs | 8/5/2013 | Designation terminated 12/18/2018 | |
| 120 | Torquin, LLC 508 Kodiak Trail Cedar Park, TX 78613 |
RC-2B (geroxane) |
Injectable | Dogs | For the treatment of nonresectable Grade II and III mast cell tumors in dogs that have not received previous therapy except corticosteroids | 8/5/2013 | Designation terminated 12/18/2018 | |
| 121 | Compan Pharmaceuticals, LLC 78-6827 Kuhinanui Street Kailua Kona, HI 96740 |
Piroxicam | Oral | Dogs | For the treatment of transitional cell carcinoma (TCC) of the bladder in dogs | 10/22/2013 | Designation terminated at sponsor's request 2/14/2018 | |
| 122 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Strontium chloride hexahydrate | Immersion | Pacific salmon fry | For the skeletal marking of Pacific salmon fry in freshwater | 11/7/2013 | ||
| 123 | AQUI-S New Zealand Ltd Unit 5, 6 Aglionby Street P.O. Box 44-269 Lower Hutt, New Zealand |
Eugenol AQUI-S 20E |
Immersion | Saltwater finfish | To sedate saltwater finfish, except for saltwater salmonids, to handleable condition | 3/3/2014 | ||
| 124 | Axcentive SARL Chemin de Champouse 13320 Bouc Bel Air France |
Chloramine-T HALAMID AQUA |
Immersion | Freshwater-reared finfish (except walleye) | For the control of mortality in all freshwater-reared coolwater finfish (except walleye) due to external columnaris disease associated with Flavobacterium columnare | 3/17/2014 | ||
| 125 | Aqua Pharma U.S., Inc. 12015 115th Avenue NE Suite 120 Kirkland, WA 98034 |
Hydrogen peroxide 50% INTEROX PARAMOVE 50 |
Immersion | Saltwater-reared Atlantic salmon | For treatment of amoebic gill disease (Neoparamoeba spp.) on saltwater-reared Atlantic salmon (Salmo salar) | 6/25/2014 | ||
| 126 | Assisi Research Laboratories, LLC 220 Pinewood Drive Michigan City, IN 46360 |
Asparaginase | Injectable | Dogs | For the induction of remission of multicentric lymphoma in dogs | 2/6/2015 | ||
| 127 | Nexcyon Pharmaceuticals, Inc. P.O. Box 259158 Madison, WI 53725 |
ACTH 1-24 Adrenocorticotropic hormone | Injectable | Dogs | For use as a diagnostic aid in testing for adrenal insufficiency in dogs | 5/15/2015 | Designation terminated at sponsor's request 9/19/2017 | |
| 128 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared warmwater finfish (except channel catfish) | For the control of mortality in freshwater-reared warmwater finfish (except channel catfish) due to external columnaris disease associated with Flavobacterium columnare | 5/22/2015 | NADA 141-255 approved 7/26/2019 | |
| 129 | Elanco US, Inc. 2500 Innovation Way Greenfield, IN 46140 |
Lufenuron IMVIXA |
Type A medicated article | Atlantic salmon | To prevent and control sea lice, Lepeophtheirus salmonis and Caligus spp., on Atlantic salmon | 6/9/2015 | ||
| 130 | ARK Animal Health 6042 Cornerstone Court, Suite D San Diego, CA 92121 |
Resiniferatoxin | Injectable | Dogs | For the control of pain associated with bone cancer in dogs | 6/19/2015 | ||
| 131 | Veiove Animal Health, Inc. 10451 Roselle Street #200 San Diego, CA 92121 |
SP-SAP (Substance P & Saporin) |
Injectable | Dogs | For the control of pain associated with bone cancer in dogs | 7/9/2015 | Designation terminated 3/28/2019 | |
| 132 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Florfenicol AQUAFLOR |
Type A medicated article | Penaeid shrimp | For the control of mortality due to vibriosis associated with Vibrio harveyi, V. penaeicida or V.parahaemolyticus in penaeid shrimp | 7/24/2015 | Designation terminated at sponsor's request 9/22/2021 | |
| 133 | Rhizen Pharmaceutical, SA Fritz-Courvoisier 40 CH-2300 La Chax-de-Fonds Switzerland |
RV1001 [a PI3Kδ inhibitor] |
Oral | Dogs | For the treatment of lymphoma in dogs | 7/29/2015 | Designation terminated 5/29/2020 | |
| 134 | EirGen Pharma Ltd. Westside Business Park Old Kilmeaden Road Waterford, Ireland |
Chlorambucil | Oral | Dogs | For maintenance therapy in dogs with chronic lymphocytic leukemia following an induction protocol of chemotherapy | 9/16/2015 | ||
| 135 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Fenbendazole SAFE-GUARD |
Type A medicated article | Quail | For the treatment and control of adult Heterakis gallinae and Capillaria spp. in quail | 2/10/2016 | ||
| 136 | Intervet, Inc. (d/b/a Merck Animal Health) 2 Giralda Farms Madison, NJ 07940 |
Fenbendazole SAFE-GUARD |
Type A medicated article | Quail | For the control of Oxyspirura petrowi and Aulonocephalus spp. in quail managed on hunting ranches/farms | 2/10/2016 | ||
| 137 | Jaguar Animal Health, Inc. 200 Pine Street, Suite 400 San Francisco, CA 94104 |
Crofelemer CANALEVIA |
Oral | Dogs | For the treatment of chemotherapy-induced diarrhea in dogs | 2/19/2016 | ||
| 138 | Nova Eel, Inc. 2161 Armcrescent Drive Halifax, Nova Scotia B3L 3C8 Canada |
Estradiol | Type A medicated article | American eel | For increased rate of weight gain in American eels fed in recirculating aquaculture systems | 7/26/2017 | 8/10/2018 | |
| 139 | Assisi Research Laboratories, LLC 220 Pinewood Drive Michigan City, IN 46360 |
Dactinomycin | Injectable | Dogs | For the treatment of relapsed or refractory lymphoma in dogs | 8/18/2017 | Designation terminated at sponsor's request 8/26/2020 | |
| 140 | PHARMAQ AS Harbitzalleen 5 P.O. Box 267 Skoyen N-0213 Oslo, Norway |
Sulfadimethoxine & ormetoprim ROMET 30 |
Type A medicated article | Catfish | For the control of mortality due to bacterial hemorrhagic septicemia associated with Aeromonas hydrophila in catfish | 1/22/2018 | ||
| 141 | PHARMAQ AS Harbitzalleen 5 P.O. Box 267 Skoyen N-0213 Oslo, Norway |
Sulfadimethoxine & ormetoprim ROMET 30 |
Type A medicated article | Freshwater salmonids | For the control of mortality due to enteric redmouth disease associated with Yersinia ruckeri in freshwater salmonids | 1/22/2018 | ||
| 142 | Phibro Animal Health Glenpointe Centre East, 3rd Fl. 300 Frank W. Burr Boulevard Suite 21 Teaneck, NJ 07666 |
Oxytetracycline TERRAMYCIN 200 for Fish |
Type A medicated article | Freshwater salmonids | For marking the skeletal tissue of freshwater-reared salmonids weighing up to 55 grams | 3/20/2018 | NADA 038-439 approved 11/21/2018 |
|
| 143 | Esplin Organic Solutions LLC 2500 South State Street, D240 Salt Lake City, UT 84115 |
Paenibacillus larvae-specific bacteriophage cocktail BROODSAFE |
Oral | Honey bees | For treatment of American Foulbrood (AFB) caused by Paenibacillus larvae in honey bees (Apis mellifera) | 6/8/2018 | Designation terminated at sponsor's request 4/12/2019 |
|
| 144 | Esplin Organic Solutions LLC 2500 South State Street, D240 Salt Lake City, UT 84115 |
Paenibacillus larvae-specific bacteriophage cocktail BROODSAFE |
Oral | Honey bees | For prevention of American Foulbrood (AFB) caused by Paenibacillus larvae in honey bees (Apis mellifera) in hives at high risk for AFB | 6/8/2018 | Designation terminated at sponsor's request 4/12/2019 |
|
| 145 | VetDC, Inc. 320 E. Vine Drive, Suite 101 Fort Collins, CO 80524 |
VDC-597 | Oral | Dogs | For the adjuvant treatment of splenic hemangiosarcoma following splenectomy in dogs | 8/16/2018 | ||
| 146 | AquaTactics LLC 12015 115th Avenue NE Suite 120 Kirkland, WA 98034 |
Erythromycin thiocyanate AQUAMYCIN 100 |
Type A medicated article | Freshwater salmonids | For the control of mortality due to bacterial kidney disease associated with Renibacterium salmoninarum in freshwater-reared salmonids | 9/26/2018 | ||
| 147 | Pathogenes, Inc. P.O. Box 970 Fairfield, FL 32634 |
Levamisole HCl NEUROQUEL |
Oral | Horses | For the control of clinical signs associated with polyneuritis equi (PNE) in horses | 10/31/2018 | ||
| 148 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
Hydrogen peroxide 35% PEROX-AID |
Immersion | Freshwater-reared coolwater and warmwater finfish fingerlings and adults | For the control of mortality in freshwater-reared coolwater and warmwater finfish fingerlings and adults due to saprolegniasis associated with fungi in the family Saprolegniaceae | 1/29/2019 | NADA 141-255 approved 7/26/2019 | |
| 149 | Kindred Biosciences, Inc. 1555 Bayshore Highway Burlingame, CA 94010 |
Anti-equine tumor necrosis factor (TNF) antibody | Injectable | Horses (neonatal foals) | As an adjunctive therapy to improve survival in neonatal foals being treated for sepsis | 3/26/2019 | ||
| 150 | Okava Pharmaceuticals, Inc. 2047 Polk Street Unit A San Francisco, CA 94109 |
Mycophenolate sodium | Oral | Dogs at least 12 months of age | For adjunctive therapy for the treatment of newly-diagnosed idiopathic (non-associative) immune-mediated hemolytic anemia (IMHA) in dogs at least 12 months of age | 11/8/2019 | ||
| 151 | Renexxion LLC 120 Hatona Drive Santa Rosa, CA 95403 |
Prucalopride | Injectable | Horses | For the treatment of post-operative ileus in horses following abdominal surgery | 11/26/2019 | Designation terminated at sponsor's request 1/13/2021 | |
| 152 | DelTaq Fish Health, LLC 126 Deer Creek Drive Scott, MS 38772 |
Gonadotropin Releasing-Hormone (GnRH) IIa | Injectable | Female ictalurids | For use as a spawning aid for female ictalurids | 12/26/2019 | ||
| 153 | Syndel USA 1441 W. Smith Road Ferndale, WA 98248 |
17alpha-methyltestosterone | Medicated feed | Tilapia | For the production of predominantly (>80%) male populations of tilapia | 1/27/2020 | ||
| 154 | Elanco US Inc. 2500 Innovation Way Greenfield, IN 46140 |
Enrofloxacin BAYTRIL 100 |
Injectable | Cattle: replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age) | For the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves | 3/3/2020 | Application 141-527 Conditionally approved 4/2/2020 | |
| 155 | Anivive Lifesciences, Inc. 3250 Airflite Way Long Beach, CA 90807 |
Epidermal Growth Factor bispecific angiotoxin (eBAT) | Injectable | Dogs | For the treatment of splenic hemangiosarcoma after splenectomy and prior to anthracycline treatment in dogs | 5/1/2020 | ||
| 156 | Armada Animal Health, LLC 345 E. 94th Street #PHE New York, NY 10128 |
Carboplatin | Injectable intra-tumoral | Dogs | For the treatment of non-metastatic squamous cell carcinoma in dogs that have not received previous chemotherapy or radiotherapy | 9/10/2020 | ||
| 157 | Trophogen, Inc. 9430 Key West Ave., Suite 155 Rockville, MD 20850 |
Recombinant ovine follicle-stimulating hormone analog | Injectable | Sheep | For the induction of superovulation in sheep | 10/28/2020 | ||
| 158 | Renexxion LLC 120 Hatona Drive Santa Rosa, CA 95403 |
Naronapride | Injectable | Horses | For the treatment of post-operative ileus following abdominal surgery in horses | 2/23/2021 | ||
| 159 | VetMed Therapeutics, Inc. 224 North Cliff Drive Gulf Breeze, FL 32561 |
Clostridium botulinum toxin type A | Injectable | Horses | For the management of acute laminitis in horses | 3/30/2021 | ||
| 160 | Anivive Lifesciences, Inc. 3250 Airflite Way Long Beach, CA 90807 |
Doxorubicin | Injectable | Dogs | For the treatment of lymphoma in dogs | 7/14/2021 |