Prescription to Over-the-Counter (OTC) Switch List
January 1 through March 17, 2022
NDA | Drug Name | Purpose | Approval Date |
---|---|---|---|
NDA 215712 | Nasonex 24HR Allergy (mometasone furoate) nasal spray, 50 mcg/spray, metered | Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose | AP 03-17-22 |
January 1 through December 31, 2021
NDA | Drug Name | Purpose | Approval Date |
---|---|---|---|
NDA 022134/S-008 | Lastacaft (alcaftadine ophthalmic solution), 0.25% | Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander | AP 12-10-21 |
NDA 213872 | Astepro Allergy and Children’s Astepro Allergy (azelastine hydrochloride) nasal spray, 0.15% |
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose |
AP 6-17-21 |
January 1 through December 31, 2020
NDA | Drug Name | Purpose | Approval Date |
---|---|---|---|
NDA 202736/S-006 | Sklice (ivermectin) lotion, 0.5% |
Treats head lice infestation |
AP 10-27-20 |
NDA 206276/S-005 | Pataday Once Daily Relief (olopatadine hydrochloride, 0.7%) |
Temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander |
AP 7-13-20 |
NDA 22122/S-014 | Voltaren Arthritis Pain (diclofenac sodium) |
Temporary relief of arthritis pain -hand, wrist, elbow (upper body areas) |
AP 2-14-20 |
NDA 020688/S-032 | Pataday Twice Daily Relief (olopatadine hydrochloride, 0.1%) | Temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander | AP 2-14-20 |
NDA 021545/S-022 | Pataday Once Daily Relief (olopatadine hydrochloride, 0.2%) | Temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander | AP 2-14-20 |
January 1 through December 31, 2019
There are no switches for this period of time.
January 1 through December 31, 2018
There are no switches for this period of time.
January 1 through December 31, 2017
NDA
|
Drug Name
|
Purpose
|
Approval Date
|
---|---|---|---|
NDA 209089
|
Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets
|
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose; sneezing; itching of nose or throat; itchy, watery eyes (allergic rhinitis)
|
AP 1-31-17
|
NDA 209090 | Xyzal Allergy 24HR (levocetirizine dihydrochloride) solution | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose; sneezing; itching of nose or throat; itchy, watery eyes (allergic rhinitis) | AP 1-31-17 |
January 1 through December 31, 2016
NDA
|
Drug Name
|
Purpose
|
Approval Date
|
---|---|---|---|
NDA 022051/S-013
|
Flonase® Sensimist Allergy Relief (fluticasone furoate)
|
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; itchy, watery eyes (allergic rhinitis)
|
AP 8-2-16
|
NDA 020380/S-010 | Differin Gel® (adapalene), 0.1% | Anti Acne | AP 7-8-16 |
January 1 through December 31, 2015
NDA
|
Drug Name
|
Purpose
|
Approval Date
|
---|---|---|---|
NDA 20746/S-032
|
Rhinocort Allergy Spray (budesonide)
|
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose (allergic rhinitis)
|
AP 3-23-15
|
January 1 through December 31, 2014
NDA
|
Drug Name
|
Purpose
|
Approval Date
|
---|---|---|---|
NDA 204655
|
Nexium 24 HR (esomeprazole magnesium)
|
Frequent heartburn
|
AP 3-28-14
|
NDA 205434
|
Flonase Allergy Relief (fluticasone proprionate)
|
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; itchy, watery eyes (allergic rhinitis)
|
AP 7-23-14
|
January 1 through December 31, 2013
NDA
|
Drug Name
|
Purpose
|
Approval Date
|
---|---|---|---|
NDA 202211
|
Oxytrol for Women
|
Overactive bladder
|
AP 1-25-13
|
NDA 020468/S-035 | Nasacort Allergy 24HR (nasal spray) | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose (allergic rhinitis) | AP 10-11-13 |
January 1 through December 31, 2012
There are no switches for this period of time.
January 1 through December 31, 2011
NDA
|
Drug Name
|
Purpose
|
Approval Date
|
---|---|---|---|
NDA 20-786/S-027
|
Allegra D 12 hr
|
Antihistamine
|
AP 1-24-11
|
NDA 21-704/S-008
|
Allegra 24 hr
|
Antihistamine
|
AP 1-24-11
|
NDA 20872/S-023
NDA 201-373
NDA 21-909/S-003
|
Allegra
|
Antihistamine
|
AP 1-25-11
|
January 1 through December 31, 2010
There are no switches for this period of time.
January 1 through December 31, 2009
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 22-3272 | Prevacid 24 HR | Acid reducer/PPI | AP 5-18-09 |
NDA 22-2812 | Zegerid OTC | Acid reducer/PPI | AP 12-1-09 |
January 1 through December 31, 2008
There are no switches for this period of time
January 1 through December 31, 2007
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 21-8872 | alli | Weight Loss Aid | AP 2-7-07 |
NDA 21-150/S-007 | Zyrtec-D |
Antihistamine and Nasal Decongestant |
AP 11-9-07 |
NDA 22-155 | Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (solution) | Antihistamine | AP 11-16-07 |
NDA 21-621/S-005 | Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (chewable tablets) | Antihistamine | AP 11-16-07 |
NDA 19-835/S-022 | Zyrtec Allergy and Zyrtec Hives Relief (tablets) | Antihistamine | AP 11-16-07 |
January 1 through December 31, 2006
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 21-958 | Lamisil Derm Gel | Topical Antifungal | AP 7-24-06 |
NDA 21-045 | Plan B | Emergency Contraceptive | AP 8-24-06 |
NDA 22-015 | MiraLax | Laxative | AP 10-6-06 |
NDA 21-066 | Zaditor | Antihistamine Eye Drop | AP 10-19-06 |
NDA 21-996 | Alaway | Antihistamine Eye Drop | AP 12-1-06 |
January 1 through December 31, 2005
There are no switches for this period of time.
January 1 through December 31, 2004
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 21-6201 | Mucinex DM ER Tablet | Expectorant/Cough Suppressant | AP 4-29-04 |
NDA 21-5851 | Mucinex D ER Tablet | Expectorant/Decongestant | AP 6-22-04 |
January 1 through December 31, 2003
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 21-2292 | Prilosec OTC | Acid reducer/PPI | AP 6-20-03 |
NDA 19-658/S-020 NDA 20-704/S-009 NDA 20-641/S-011 |
Claritin Hives Relief Tablets, Reditabs and Solution | Antihistamine | AP 11-19-03 |
January 1 through December 31, 2002
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 20-150 | Nicotrol TD | Smoking Cessation | AP 3-21-02 |
NDA 21-2821 | Mucinex ER Tablet | Expectorant | AP 7-12-02 |
NDA 19-658/S-018 NDA 20-704/S-008 NDA 20-641/S-009 |
Claritin Tablets, Reditabs and Solution | Antihistamine | AP 11-27-02 |
NDA 19-670/S-018 | Claritin-D | Antihistamine/Decongestant | AP 11-27-02 |
NDA 20-470/S-016 | Claritin-D 24-hour | Antihistamine/ Decongestant | AP 11-27-02 |
January 1 through December 31, 2001
NDA |
Drug Name |
Purpose |
Approval Date |
---|---|---|---|
NDA 21-261 | Monistat 3 combo pk | Vaginal Antifungal | AP 2-2-01 |
NDA 21-308 | Monistat 1 (supp) | Vaginal Antifungal | AP 6-29-01 |
NDA 21-307 | Lotrimin Ultra | Topical Antifungal | AP 12-7-01 |
1These NDAs are not true switches since these products were marketed as prescription products without an approved NDA prior to being approved for OTC marketing under an NDA.
2These NDAs are not true switches since the conditions of use were not marketed as a prescription product under an approved NDA prior to being approved for marketing OTC.