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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-035Nasacort Allergy 24HR (nasal spray)Allergic rhinitisAP 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 22-3272Prevacid 24 HRAcid reducer/PPIAP 5-18-09
NDA 22-2812Zegerid OTCAcid reducer/PPIAP 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 21-8872alliWeight Loss AidAP 2-7-07
NDA 21-150/S-007Zyrtec-D

Antihistamine and

Nasal Decongestant

AP 11-9-07
NDA 22-155Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (syrup)AntihistamineAP 11-16-07
NDA 21-621/S-005Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (chewable tablets)AntihistamineAP 11-16-07
NDA 19-835/S-022Zyrtec Allergy and Zyrtec Hives Relief (tablets)AntihistamineAP 11-16-07

January 1 through December 31, 2006

NDA

Drug Name

Purpose

Approval Date

NDA 21-958Lamisil Derm GelTopical AntifungalAP 7-24-06
NDA 21-045Plan BEmergency ContraceptiveAP 8-24-06
NDA 22-015MiraLaxLaxativeAP 10-6-06
NDA 21-066ZaditorAntihistamine Eye DropAP 10-19-06
NDA 21-996AlawayAntihistamine Eye DropAP 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 21-6201Mucinex DM ER TabletExpectorant/Cough SuppressantAP 4-29-04
NDA 21-5851Mucinex D ER TabletExpectorant/DecongestantAP 6-22-04

January 1 through December 31, 2003

NDA

Drug Name

Purpose

Approval Date

NDA 21-2292Prilosec OTCAcid reducer/PPIAP 6-20-03
NDA 19-658/S-020
NDA 20-704/S-009
NDA 20-641/S-011
Claritin Hives Relief Tablets, Reditabs and SyrupAntihistamineAP 11-19-03

January 1 through December 31, 2002

NDA

Drug Name

Purpose

Approval Date

NDA 20-150Nicotrol TDSmoking CessationAP 3-21-02
NDA 21-2821Mucinex ER TabletExpectorantAP 7-12-02
NDA 19-658/S-018
NDA 20-704/S-008
NDA 20-641/S-009
Claritin Tablets, Reditabs and SyrupAntihistamineAP 11-27-02
NDA 19-670/S-018Claritin-DAntihistamine/DecongestantAP 11-27-02
NDA 20-470/S-016Claritin-D 24-hourAntihistamine/ DecongestantAP 11-27-02

January 1 through December 31, 2001

NDA

Drug Name

Purpose

Approval Date

NDA 21-261Monistat 3 combo pkVaginal AntifungalAP 2-2-01
NDA 21-308Monistat 1 (supp)Vaginal AntifungalAP 6-29-01
NDA 21-307Lotrimin UltraTopical AntifungalAP 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.