Competitive Generic Therapy Approvals
The Office of Generic Drugs is providing a public list of all approved abbreviated new drug application (ANDAs) for drug products that received a Competitive Generic Therapy (CGT) designation under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and is also noting which ANDAs on this list cover drug products that were also eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act. This list will be updated on a bi-weekly basis with new ANDA approvals where at least one of the drug products, i.e., one of the strengths, in the approved application received a CGT designation.
The Agency is including the following information for individual drug products on the CGT Approvals List:
- Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number
This column reflects the proprietary name, if any, of the RLD and its NDA number. - ANDA Number
- ANDA Applicant
- Active Ingredient Name, Dosage Form, Strength
This column reflects the established (nonproprietary) name of the active ingredient(s) in the drug product, as well as the product’s dosage form and strength(s). - Date of Approval
This column indicates the date on which an ANDA for a CGT-designated drug product(s) received final approval. - Eligible for CGT Exclusivity
In this column, drug products that, at the time of approval, were eligible for CGT exclusivity will be indicated with a “Yes,” while drug products that were not eligible for CGT exclusivity at the time of approval will be indicated with a “No.” Certain products in ANDAs designated as CGTs can qualify for CGT exclusivity if the applicant is a “first approved applicant” as defined in section 505(j)(5)(B)(v) of the FD&C Act. There is only one exclusivity period available for each CGT, and receiving a CGT designation does not ensure that a drug product will be eligible for CGT exclusivity. For example, a drug product in an ANDA that receives a CGT designation will not be eligible for CGT exclusivity if there were unexpired patents or exclusivities listed in the Orange Book at the time of the original submission of the ANDA for the CGT-designated drug product. - CGT Exclusivity Forfeiture
This column indicates whether or not a drug product that was eligible for CGT exclusivity upon approval forfeited eligibility because it was not commercially marketed within 75 days after the date of approval of the ANDA (see section 505(j)(5)(D)(iv) of the FD&C Act). A forfeiture event is indicated with “Yes.” Non-forfeiture is indicated with “No.” If the forfeiture determination has not yet been made, the column will be blank, and if the CGT was not eligible for exclusivity upon approval, the column will reflect “N/A.” - Date of First Commercial Marketing of CGT with Exclusivity
This column reflects the date of first commercial marketing of a CGT by a first approved applicant of a drug product that was eligible for CGT exclusivity and did not forfeit its eligibility. The 180-day CGT exclusivity period described under section 505(j)(5)(B)(v) of the FD&C Act is triggered by the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant. This 180-day CGT exclusivity period, once triggered, blocks the approval of an ANDA for a drug that is the same as the CGT. If the CGT was not granted exclusivity, or the exclusivity was forfeited, the column will reflect “N/A.”
FDA intends that the information on the list will provide transparency to prospective applicants and other interested parties with respect to the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity. FDA believes that this information will be useful to help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition, and will also aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (as noted above, there is only one exclusivity period for each CGT). By providing the commercial marketing start date for CGT exclusivity periods, this list will also provide useful information to applicants whose ANDAs have been blocked from final approval by CGT exclusivity regarding when the exclusivity period will expire. To note, FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) also posts a Competitive Generic Therapy (CGT) code in the “Exclusivity Data” section of the Orange Book for the approved drug products eligible for 180-day CGT exclusivity upon any first approved applicant’s commercial marketing, indicating the date the 180-day CGT exclusivity will expire.
Competitive Generic Therapy Approvals
RLD Name and NDA Number | ANDA Number | ANDA Applicant | Active Ingredient Name, Dosage Form, Strength | Date of Approval | Eligible for CGT Exclusivity | CGT Exclusivity Forfeiture | Date of First Commercial Marketing of CGT with Exclusivity | ||
---|---|---|---|---|---|---|---|---|---|
122 |
Migranal Nasal Spray, NDA 020148 |
214105 | Amneal Pharmaceuticals LLC | Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) | 1/4/2022 | No | N/A | N/A | |
121 | AmBisome Liposome for Injection, NDA 050740 | 212514 | Sun Pharmaceutical Industries Inc. | Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial | 12/14/2021 | Yes | |||
120 | Timoptic Ophthalmic Solution in Ocudose, NDA 019463 | 212592 | Pharmaceutical Project Solutions, Inc. | Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials | 12/13/2021 | Yes | |||
119 | Atropine Sulfate Injection, NDA 209260 | 213561 | Hikma Pharmaceuticals USA Inc. |
Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multi-Dose Vial |
12/1/2021 | No | N/A | N/A | |
118 | Atropine Sulfate, NDA 206289 | 215624 | Apotex | Atropine Sulfate Ophthalmic Solution, USP 1% | 11/26/2021 | Yes | N/A | 11/26/2021 | |
117 | Cystadane, NDA 20576 | 214864 | Novitium Pharma | Betaine Anhydrous for Oral Solution, 180 grams/bottle | 11/23/2021 | Yes | |||
116 | Isordil, NDA 012093 | 211290 | Par Pharmaceutical, Inc. | Isosorbide Dinitrate Tablets USP, 40 mg | 11/23/2021 | Yes | N/A | 12/22/2021 | |
115 | Perforomist Inhalation Solution, NDA 022007 | 215078 | Alembic Pharmaceuticals Limited | Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial | 11/22/2021 | No | N/A | No | |
114 | Revatio, NDA 203109 | 212312 | Tris Pharma, Inc. | Sildenafil for Oral Suspension, 10 mg/mL | 11/17/2021 | No | N/A | No | |
113 | Arranon, NDA 021877 | 215037 | Zydus Pharmaceuticals (USA) Inc. | Nelarabine Injection, 250 mg/50 mL (5 mg/mL), SingleDose Vial | 11/17/2021 | Yes | |||
112 | Bactroban 2% Cream, NDA 050746 | 213053 | Aleor Dermaceuticals Limited | Mupirocin Cream USP, 2% | 11/16/2021 | Yes | N/A | 12/29/2021 | |
111 | Librax Capsules, NDA 012750 | 211476 | Teva Pharmaceuticals USA, Inc. | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 11/2/2021 | No | N/A | N/A | |
110 | Prexxartan, NDA 209139 | 214102 | Novitium Pharma, LLC | Valsartan Oral Solution, 20 mg/5 mL (4 mg/mL) | 11/2/2021 | Yes | Yes | N/A | |
109 | Monurol, NDA 050171 | 214554 | Alkem Laboratories Limited | Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet | 10/21/2021 | No | N/A | ||
108 | Decadron Tablets, NDA 011664 | 215106 | Amneal EU, Limited | Dexamethasone Tablets USP, 4 mg and 6 mg | 10/14/2021 | Yes | N/A | 4mg - 10/21/2021; 6 mg - 10/22/2021 | |
107 | Carbaglu Tablets for Oral Suspension, NDA 016636 | 213729 | Novitium Pharma, LLC | Carglumic Acid Tablets for Oral Suspension, 200 mg | 10/13/2021 | Yes | N/A | 12/20/2021 | |
106 | Mexitil Capsules, NDA 018873 | 214089 | Aavis Pharmaceuticals | Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg | 10/1/2021 | No | N/A | N/A | |
105 | Zomig Nasal Spray, NDA 021450 | 212469 | Padagis US, LLC | Zolmitriptan Nasal Spray USP, 2.5 mg/spray and 5 mg/spray | 9/30/2021 | No | N/A | N/A | |
104 | Absorica Capsules, NDA 021951 | 212333 | Upsher-Smith Laboratories, LLC | Isotretinoin Capsules USP, 10 mg, 20 mg, and 30 mg | 9/21/2021 | No | N/A | N/A | |
103 | Quinaglute ER Tablets, NDA 016647 | 212589 | Eywa Pharma, Inc. | Quinidine Gluconate Extended-Release Tablets USP, 324 mg | 9/17/2021 | Yes | |||
102 | Paxil Oral Suspension, NDA 020710 | 215003 | Novitium Pharma LLC | Paroxetine Oral Suspension, 10 mg (base)/5 mL | 9/3/2021 | Yes | N/A | 9/13/2021 | |
101 | Ortho Evra, NDA 021180 | 213977 | Teva Pharmaceuticals USA, Inc. | Onsura (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day |
8/25/2021 | No | N/A | N/A | |
100 | Aramine, NDA 009509 | 211304 | Slayback Pharma LLC | Metaraminol Bitartrate Injection USP, 100 mg (base)/10 mL (10 mg (base)/mL), Multi-Dose Vial | 8/24/2021 | Yes | Yes | N/A | |
99 | Cuprimine, NDA 019853 | 213293 | InvaGen Pharmaceuticals, Inc. | Penicillamine Capsules USP, 250 mg | 8/19/2021 | No | N/A | N/A | |
98 | Clindagel, NDA 050782 | 212842 | Solaris Pharma Corporation | Clindamycin Phosphate Gel USP, 1% | 8/13/2021 | No | N/A | N/A | |
97 | Loperamide Hydrochloride Capsules, NDA 21855 | 213070 | Strides Pharma, Inc. | Loperamide Hydrochloride Capsules USP, 2 mg (OTC) | 8/11/2021 | Yes | N/A | 10/22/2021 | |
96 | Paraflex Tablets, NDA 011300 | 215158 | Havix Group, Inc. | Chlorzoxazone Tablets USP, 250 mg | 7/29/2021 | Yes | N/A | 9/30/2021 | |
95 | Daraprim Tablets, NDA 008578 | 211271 | Alvogen | Pyrimethamine Tablets USP, 25 mg | 7/27/2021 | Yes | N/A | 10/4/2021 | |
94 | Ery-Tabs, ANDA 062298 | 211975 | Torrent Pharma Inc. | Erythromycin Delayed-Release Tablets USP, 250 mg and 500 mg | 7/26/2021 | Yes | N/A | 10/4/2021 | |
93 | Atropine Sulfate Injection USP, NDA 021146 | 212868 | Accord Healthcare Inc. | Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe | 7/26/2021 | Yes | N/A | 7/30/2021 | |
92 | Taytulla Capsules, NDA 204426 | 214292 | Amneal Pharmaceuticals | Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg | 7/20/2021 | No | N/A | N/A | |
91 | Theophylline Extended-Release Tablets, ANDA 90430 | 212184 | Glenmark Pharmaceuticals Limited | Theophylline Extended-Release Tablets, 450 mg | 6/3/2021 | Yes | No | 6/11/2021 | |
90 | Thorazine, NDA 009149 | 214542 | Genus Lifesciences Inc. | Chlorpromazine Hydrochloride Oral Concentrate USP, 30 mg/mL and 100 mg/mL | 6/2/2021 | Yes | No | 8/2/2021 | |
89 | Miacalcin Injection, NDA 017808 | 212416 | Custopharm, Inc. | Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial | 5/14/2021 | Yes | No | 5/14/2021 | |
88 | Revatio for Oral Suspension, NDA 203109 | 213014 | Hetero Labs Limited | Sildenafil for Oral Suspension, 10 mg/mL | 5/11/2021 | No | N/A | N/A | |
87 | Librax Capsules, NDA 012750 | 214698 | Dr. Reddy's Laboratories Limited | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 5/10/2021 | No | N/A | N/A | |
86 | Sodium Acetate Injection USP, NDA 018893 | 214805 | Milla Pharmaceuticals, Inc. | Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials | 5/4/2021 | Yes | No | 7/7/2021 | |
85 | Thiola, NDA 019569 | 214326 | Teva Pharmaceuticals USA, Inc. | Tiopronin Tablets, 100 mg | 4/26/2021 | No | N/A | N/A | |
84 | Librax Capsules, NDA 012750 | 214065 | Alkem Laboratories Limited | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 4/26/2021 | No | N/A | N/A | |
83 | Bentyl, NDA 007961 | 214721 | Novitium Pharma LLC | Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL | 4/23/2021 | No | N/A | N/A | |
82 | Foscavir Injection, NDA 020068 | 213001 | Gland Pharma Limited | Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) | 4/21/2021 | Yes | No | 7/1/2021 | |
81 | Thorazine Tablets, NDA 009149 | 212144 | Glenmark Pharmaceuticals Limited | Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg | 3/23/2021 | Yes | No | 3/24/2021 | |
80 | Cardizem SR Extended-Release Capsules, NDA 019471 | 212317 | Glenmark Pharmaceuticals Limited | Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg | 3/22/2021 | Yes | No | 3/30/2021 | |
79 | Atropine Sulfate Injection NDA 209260 | 213424 | Accord Healthcare Inc. | Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial | 3/19/2021 | Yes | No | 3/25/2021 | |
78 | Lotemax, NDA 020583 | 212450 | Sun Pharmaceutical Industries Inc. | Loteprednol Etabonate Ophthalmic Suspension, 0.5% | 2/26/2021 | Yes | No | 5/6/2021 | |
77 | Ortho Evra, NDA 021180 | 213950 | Amneal | Norelgestromin and Ethinyl Estradiol Transdermal System, 150/35 mcg per day | 2/25/2021 | Yes | No | 2/26/2021 | |
76 | Northera NDA 203202 | 211818 | Zydus Pharmaceuticals (USA) Inc. | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | No | N/A | N/A | |
75 | Lotemax, NDA 202872 | 212080 | Akorn Operating Company LLC | Loteprednol Etabonate Ophthalmic Gel, 0.5% | 2/10/2021 | No | N/A | N/A | |
74 | Jadenu, NDA 207968 | 214194 | Amneal | Deferasirox Oral Granules, 180 mg and 360 mg | 2/9/2021 | No | N/A | N/A | |
73 | Kenalog, NDA 011600 | 212460 | Perrigo Israel Pharmaceuticals Ltd. | Triamcinolone Acetonide Ointment USP, 0.05% | 2/5/2021 | No | N/A | N/A | |
72 | Sabril, NDA 020427 | 211539 | Dr. Reddy's Laboratories Limited | Vigabatrin Tablets USP, 500 mg | 1/29/2021 | Yes | No | 2/1/2021 | |
71 | Eveko, NDA 209905 | 212186 | Glemark Pharmaceuticals Limited | Amphetamine Sulfate Tablets USP, 5 mg and 10 mg | 1/27/2021 | No | N/A | N/A | |
70 | Mexitil, NDA 018873 | 214352 | RiconPharma LLC | Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg | 1/25/2021 | No | N/A | N/A | |
69 | Argatroban Injection, NDA 203049 | 214235 | Caplin Steriles Limited | Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial | 1/21/2021 | Yes | Yes | N/A | |
68 | Narcan, NDA 016636 | 213279 | Aurobindo Pharma Limited | Naloxone Hydrochloride Injection USP, 2 mg/mL (1 mg/mL) prefilled Syringes | 1/14/2021 | No | N/A | N/A | |
67 | Taytulla, NDA 204426 | 212706 | Slayback Pharma LLC | Merzee (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg) | 12/18/2020 | Yes | No | 1/18/2021 | |
66 | Jublia Topical Solution, NDA 203567 | 211827 | Teva Pharmaceuticals USA, Inc. |
|
12/16/2020 | No | N/A | N/A | |
65 | Jublia Topical Solution, NDA 203567 | 211851 | Perrigo Pharma International DAC | Efinaconazole Topical Solution, 10% | 12/16/2020 | NO | N/A | N/A | |
64 | Amicar, NDA 015197 | 211629 | ANI Pharmaceuticals, Inc. | Aminocaproic Acid Tablets USP, 500 mg | 12/14/2020 | No | N/A | N/A | |
63 | Morphine Sulfate Tablets, NDA 022207 | 212451 | Alkem Laboratories | Morphine Sulfate Tablets, 15 mg and 30 mg | 12/3/2020 | Yes | No | 2/11/2021 | |
62 | Depen Tablets, NDA 019854 | 212933 | Lupin Limited | Penicillamine Tablets USP, 250 mg | 11/30/2020 | No | N/A | N/A | |
61 | Alinia Tablets, NDA 021497 | 213820 | Rising Pharma Holding, Inc. | Nitazoxanide Tablets, 500 mg | 11/27/2020 | Yes | No | 12/7/2020 | |
60 | Kenalog, NDA 011600 | 213619 | Cintex Services, LLC | Triamcinolone Acetonide Ointment USP, 0.05% | 11/10/2020 | No | N/A | N/A | |
59 | Parafon Forte DSC Tablets, NDA 011529 | 212743 | Par Pharmaceutical, Inc. | Chlorzoxazone Tablets USP, 750 mg | 11/2/2020 | No | N/A | N/A | |
58 | Timoptic-XE, NDA 020330 | 212942 | Alembic Pharmaceuticals Limited | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% | 10/22/2020 | Yes | No | 11/25/2020 | |
57 | Librax Capsules, NDA 012750 | 213530 | ECI Pharmaceuticals, LLC | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 10/20/2020 | Yes | No | 10/26/2020 | |
56 | Kerydin 5% Topical Solution, NDA 204427 | 211848 | Perrigo Pharma International DAC | Tavaborole Topical Solution, 5% | 10/13/2020 | No | N/A | N/A | |
55 | Monurol, NDA 050717 | 212548 | Xiromed Pharma Espana, S.L. | Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet | 10/6/2020 | Yes | No | 10/6/2020 | |
54 | Firazyr Injection, NDA 022150 | 213054 | Dr. Reddy's Laboratories Limited | Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Pre-Filled Syringe | 10/5/2020 | No | N/A | N/A | |
53 | Claritin RediTabs, NDA 021993 | 212795 | Tenshi Kaizen Private Limited. | Loratadine Orally Disintegrating Tablets USP, 5 mg | 9/18/2020 | Yes | Yes | N/A | |
52 | Parafon Forte DSC Tablets, NDA 011529 | 212053 | i3 Pharmaceuticals | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 9/14/2020 | No | N/A | N/A | |
51 | Taclonex, NDA 22185 | 212367 | Perrigo | Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% | 9/11/2020 | No | N/A | N/A | |
50 | Nascobal, NDA 21642 | 212458 | Perrigo | Cyanocobalamin Nasal Solution 500 mcg/spray | 9/9/2020 | No | N/A | N/A | |
49 | Daptomycin, NDA 208385 | 211403 | Dr. Reddy's Laboratories Inc. | Daptomycin for Injection, 350 mg per vial (single-dose vial) |
8/31/2020 | No | N/A | N/A | |
48 | Revatio, NDA 203109 | 213041 | AptaPharma, Inc. | Sildenafil for Oral Suspension, 10mg/mL | 8/6/2020 | No | N/A | N/A | |
47 | Cuprimine, NDA 019853 | 211867 | Dr Reddy's Laboratories, Inc. | Penicillamine Capsules USP, 250 mg | 8/4/2020 | No | N/A | N/A | |
46 | Metro I.V., NDA 018900 | 212435 | Gland Pharma Limited | Metronidazole Injection USP, 500 mg/100 mL (5 mg/mL) | 8/3/2020 | Yes | Yes | N/A | |
45 | Demser, NDA 017871 | 213734 | Amneal | Metyrosine Capsules USP, 250 mg | 7/24/2020 | Yes | No | 7/30/2020 | |
44 | Mexitil, NDA 018873 | 213500 | CrossMedika SA | Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg | 7/22/2020 | Yes | No | 7/22/2020 | |
43 | Parafon Forte DSC Tablets, NDA 011529 | 212898 | Teva Pharmaceuticals USA, Inc. | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 6/17/2020 | No | N/A | N/A | |
42 | Albenza Tablets, NDA 020666 | 211636 | Lupin Limited | Albendazole Tablets USP, 200 mg | 6/10/2020 | Yes | Yes | N/A | |
41 | Kenalog, NDA 011600 | 212356 | Strides Pharma Inc. | Triamcinolone Acetonide Ointment USP, 0.05% | 6/1/2020 | No | N/A | N/A | |
40 | Revatio for Oral Suspension, NDA 203109 | 211534 | Teva Pharmaceuticals USA, Inc. | Sildenafil for Oral Suspension, 10 mg/mL | 5/29/2020 | No | N/A | N/A | |
39 | Parafon Forte DSC Tablets, NDA 011529 | 212185 | Glenmark Pharmaceuticals Limited | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 5/26/2020 | No | N/A | N/A | |
38 | Bentyl (Dicyclomine Hydrochloride), NDA 007961 | 212286 | Hikma Pharmaceuticals USA Inc. | Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL | 5/22/2020 | Yes | No | 5/22/2020 | |
37 | Migranal Nasal Spray, NDA 020148 | 212907 | Cipla Limited | Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) | 5/20/2020 | Yes | No | 5/23/2020 | |
36 | K-Dur (Potassium Chloride), NDA 019439 |
212861 | Amneal | Potassium Chloride Extended-Release Tablets USP, 15 mEq | 5/8/2020 | Yes | Yes | N/A | |
35 | Butrans (Buprenorphine), NDA 021306 |
211586 | Amneal | Buprenorphine Transdermal System, 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour | 4/14/2020 | Yes (7.5 mcg/hour); No (20 mcg/hour); No (15 mcg/hour); No (10 mcg/hour); No (5 mcg/hour) |
No | 4/16/2020 | |
34 | Adrenalin, NDA 204640 | 211880 | International Medication Systems, Limited | Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) | 4/24/2020 | No | N/A | N/A | |
33 | Narcan, NDA 16636 |
213209 | Dr. Reddy's Laboratories Limited | Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) | 3/16/2020 | Yes | No | 3/18/2020 | |
32 | Tepadina, NDA 208264 | 213049 | MSN Pharmaceuticals Inc. | Thiotepa for Injection USP, 15mg/vial and 100 mg/vial | 3/4/2020 | No | N/A | N/A | |
31 | Depen, NDA 19854 | 211497 | Teva Pharmaceuticals USA, Inc. | Penicillamine Tablets USP, 250mg | 2/13/2020 | Yes | Yes | N/A | |
30 | Mestinon, NDA 15193 | 212702 | Amneal | Pyridostigmine Bromide Oral Syrup, USP 60 mg/5 mL | 1/10/2020 | No | N/A | N/A | |
29 | Valium, NDA 016087 | 211998 | Beloteca, Inc. | Diazepam Injection USP, 50 mg/10 mL (5 mg/mL) | 12/26/2019 | Yes | Yes | N/A | |
28 | Proglycem Oral Suspension, NDA 017453 | 211050 | e5 Pharma, LLC | Diazoxide Oral Suspension USP, 50 mg/mL, | 12/20/2019 | Yes | No | 12/20/2019 | |
27 | Triamcinolone Acetonide, ANDA 089595 | 212384 | Encube | Triamcinolone Acetonide Ointment USP, 0.05% | 11/29/2019 | Yes | No | 12/2/2019 | |
26 | Amicar, NDA 15197 | 212492 | Amneal | Aminocaproic Acid Tablets USP, 500 mg | 11/27/2019 | Yes | No | 12/3/2019 | |
25 | Chlorzoxazone Tablets, ANDA 40861 | 212253 | Novitium Pharma | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 11/27/2019 | Yes | No | 11/27/2019 | |
24 | Revatio, NDA 203109 | 212440 | Alkem Laboratories | Sildenafil for Oral Suspension, 10 mg/mL | 11/27/2019 | No | N/A | N/A | |
23 | Revatio, NDA 203109 | 212883 | Ajanta Pharma | Sildenafil for Oral Suspension, 10 mg/mL | 11/27/2019 | No | N/A | N/A | |
22 | Butalbital and Acetaminophen, ANDA 207313 | 213115 | Granules | Butalbital and Acetaminophen Capsules, 50 mg/300 mg | 11/25/2019 | Yes | No | 1/30/2020 | |
21 | Eryped, NDA 050207 | 211991 | Par Pharmaceutical Inc. | Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg /5 mL and 400 mg/ 5 mL | 10/23/2019 | Yes | Yes (400 mg) | 11/11/2019 (200 mg) | |
20 | Rapamune, NDA 21083 | 211406 | Apotex | Sirolimus Oral Solution, 1 mg/mL | 10/22/2019 | No | N/A | N/A | |
19 | Digoxin, NDA 21648 | 213000 | Novitium Pharma | Digoxin Oral Solution USP, 0.05 mg/mL | 10/4/2019 | Yes | No | 10/4/2019 | |
18 | Elidel, NDA 21302 | 211769 | Glenmark | Pimecrolimus Cream, 1% | 8/29/2019 | No | N/A | N/A | |
17 | Orfadin, NDA 21232 | 211041 | Novitium Pharma | Nitisinone Capsules, 2 mg, 5 mg and 10 mg | 8/26/2019 | No | N/A | N/A | |
16 | Amicar, NDA 15230 | 212780 | Amneal | Aminocaproic Acid Oral Solution USP, 0.25 g/mL | 8/23/2019 | Yes | No | 8/30/2019 | |
15 | Aleve PM, NDA 205352 | 211830 | Apotex | Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220/25 mg | 8/22/2019 | Yes | Yes | N/A | |
14 | Levocarnitine, NDA 19257 | 211676 | Novitium Pharma | Levocarnitine Sugar Free Oral Solution, 1 g/mL | 8/14/2019 | Yes | No | 10/16/2019 | |
13 | Daptomycin, NDA 208385 | 212667 | Accord | Daptomycin for Injection, 350 mg/vial | 7/12/2019 | Yes | No | 7/16/2019 | |
12 | Hemabate, NDA 17989 | 211941 | Dr. Reddy's Laboratories | Carboprost Tromethamine Injection, 250 mcg/mL | 7/2/2019 | Yes | No | 7/2/2019 | |
11 | Cuprimine, NDA 19853 | 210976 | Watson | Penicillamine Capsule, 250 mg | 6/24/2019 | Yes | No | 6/25/2019 | |
10 | Revatio, NDA 203109 | 212260 | Novitium Pharma | Sildenafil Citrate for Oral Suspension, 10 mg/mL | 5/31/2019 | Yes | No | 5/31/2019 | |
9 | Navane, NDA 16584 | 211642 | Novitium Pharma | Thiothixene Capsules, 1 mg, 2 mg, 5 mg and 10 mg | 4/5/2019 | Yes | No | 4/5/2019 | |
8 | Methergine, NDA 06035 | 211455 | Teva | Methylergonovine Maleate Tablets, 0.2 mg | 3/20/2019 | No | N/A | N/A | |
7 | Mestinon, NDA 15193 | 211694 | Novitium Pharma | Pyridostigmine Bromide Oral Syrup, 60 mg/5 mL | 3/8/2019 | Yes | No | 3/8/2019 | |
6 | Rapamune, NDA 21083 | 211040 | Novitium Pharma | Sirolimus Solution, 1 mg/mL | 1/28/2019 | No | N/A | N/A | |
5 | Westcort, NDA 01872 | 211750 | Glenmark | Hydrocortisone Valerate Ointment, 0.2 % | 12/14/2018 | Yes | No | 1/17/2019 | |
4 | Levo-Dromoran, NDA 08720 | 211484 | Par Pharmaceuticals | Levorphanol Tartrate Tablet, 2 mg | 12/13/2018 | No | N/A | N/A | |
3 | Amphetamine, ANDA 200166 | 211139 | Amneal | Amphetamine Sulfate Tablet, 5 mg and 10 mg | 9/26/2018 | Yes | No | 9/27/2018 (5 mg) 10/1/2018 (10 mg) |
|
2 | Methergine, NDA 06035 | 211483 | Amneal | Methylergonovine Maleate Tablets, 0.2 mg | 9/10/2018 | Yes | No | 9/21/2018 | |
1 | Potassium Chloride, NDA 206814 | 211067 | Apotex | Potassium Chloride Oral Solution, 20 mEq/15 mL and 40 mEq/15 mL | 8/8/2018 | Yes | No | 8/29/2018 (20 mg) 9/7/2018 (40 mg) |