About FDA
Prescription to Over-the-Counter (OTC) Switch List
January 1 through December 31, 2013
NDA | Drug Name | Purpose | Approval Date |
|---|---|---|---|
NDA 202211 | Oxytrol for Women | Overactive bladder | AP 1-25-13 |
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 (syrup) | 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 Syrup | 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 Syrup | 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.
