About FDA

Prescription to Over-the-Counter (OTC) Switch List

January 1 through July 23, 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)
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) 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 (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. 

Page Last Updated: 01/09/2015
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