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About FDA
Rx-to-OTC Switch List
January 1 through October 1, 2008
| There are no switches for this period of time. |
January 1 through December 31, 2007
| NDA |
Drug Name |
Purpose |
Approval Date |
| NDA 21-887 |
Orlistat |
Weight Loss Aid |
2-7-2007 |
| NDA 21-150/S-007 |
Zyrtec-D |
Antihistamine and Nasal Decongestant |
11-9-2007 |
| NDA 22-155 |
Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (syrup) |
Antihistamine |
11-16-2007 |
| NDA 21-621/S-005 |
Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (chewable tablets) |
Antihistamine |
11-16-2007 |
| NDA 19-835/S-022 |
Zyrtec Allergy and Zyrtec Hives Relief (tablets) |
Antihistamine |
11-16-2007 |
January 1 through December 31, 2006
| NDA |
Drug Name |
Purpose |
Approval Date |
| NDA 21-958 |
Lamisil Derm Gel |
Topical Antifungal |
7-24-2006 |
| NDA 21-045 |
Plan B |
Emergency Contraceptive |
8-24-2006 |
| NDA 22-015 |
MiraLax |
Laxative |
10-6-2006 |
| NDA 21-066 |
Zaditor |
Antihistamine Eye Drop |
10-19-2006 |
| NDA 21-698 |
Zantac 150 |
Acid reducer |
8-21-2004 |
January 1 through December 31, 2004
| NDA |
Drug Name |
Purpose |
Approval Date |
| NDA 21-6201 |
Mucinex DM ER Tablet |
Expectorant/Cough Suppressant |
4-29-2004 |
| NDA 21-5851 |
Mucinex D ER Tablet |
Expectorant/Decongestant |
6-22-2004 |
| NDA 21-698 |
Zantac 150 |
Acid reducer |
8-21-2004 |
January 1 through December 31, 2003
| NDA |
Drug Name |
Purpose |
Approval Date |
| NDA 21-229 |
Prilosec OTC |
Acid reducer/PPI |
6-20-2003 |
| NDA 20-325/S-015 |
Pepcid AC Maximum Strength |
Acid Reducer/H2 blocker |
9-23-2003 |
| NDA 19-658 |
Claritin Tablets |
Antihistamine |
11-19-2003 |
January 1 through December 31, 2002
| NDA |
Drug Name |
Purpose |
Approval Date |
| NDA 20-150 |
Nicotrol TD |
Smoking Cessation |
3-21-2002 |
| NDA 21-2821 |
Mucinex ER Tablet |
Expectoran |
7-12-2002 |
| NDA 20-641 |
Claritin Syrup |
Antihistamine |
11-27-2002 |
| NDA 20-704 |
Claritin Reditabs |
Antihistamine |
11-27-2002 |
| NDA 19-670 |
Claritin-D |
Antihistamine/Decongestant |
11-27-2002 |
| NDA 20-470 |
Claritin-D 24-hour |
Antihistamine/Decongestant |
11-27-2002 |
January 1 through December 31, 2001
| NDA |
Drug Name |
Purpose |
Approval Date |
| NDA 21-261 |
Monistat 3 combo pk |
Vaginal Antifungal |
2-2-2001 |
| NDA 21-308 |
Monistat 1 (supp) |
Vaginal Antifungal |
6-29-2001 |
| NDA 21-307 |
Lotrimin Ultra |
Topical Antifungal |
12-07-2001 |
These NDAs are not true switches because these products were marketed as prescription products without an approved NDA prior to being approved for OTC marketing under an NDA.
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