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  1. Center for Drug Evaluation and Research (CDER)

Prescription to Nonprescription Switch List

2023

NDA Drug Name Purpose Approval Date 
NDA 17031/S-041 Opill (norgestrel) tablet, 0.075 mg Prevention of pregnancy AP 7-13-23
NDA 208411/S-006 Narcan (naloxone hydrochloride, 4 mg) nasal spray Treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression AP 3-29-23

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

2021

NDA Drug Name Purpose Approval Date 
NDA 22134/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

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)
-foot, ankle, knee (lower body areas)

AP 2-14-20
NDA 20688/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 21545/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

2019
There are no switches for this period of time.

2018
There are no switches for this period of time.

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

2016

NDA

Drug Name

Purpose

Approval Date

NDA 22051/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 20380/S-010 Differin Gel® (adapalene), 0.1% Anti Acne AP 7-8-16

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

2014

NDA

Drug Name

Purpose

Approval Date

NDA 2046551

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

2013

NDA
Drug Name
Purpose
Approval Date
NDA 202211
Oxytrol for Women
Overactive bladder
AP 1-25-13
NDA 20468/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
NDA 222831 Zegerid OTC (omeprazole, 20mg and sodium bicarbonate, 1680 mg) powder for oral suspension Frequent heartburn AP 6-17-13

2012
There are no switches for this period of time.

2011

NDA
Drug Name
Purpose
Approval Date
NDA 20786/S-027
Allegra D 12 hr
Antihistamine
AP 1-24-11
NDA 21704/S-008
Allegra 24 hr
Antihistamine
AP 1-24-11
NDA 20872/S-023
NDA 201373
NDA 21909/S-003
Allegra
Antihistamine
AP 1-24-11

2010
There are no switches for this period of time.  

2009

NDA

Drug Name

Purpose

Approval Date

NDA 223271 Prevacid 24 HR Acid reducer/PPI AP 5-18-09
NDA 222811 Zegerid OTC Acid reducer/PPI AP 12-1-09

2008
There are no switches for this period of time  

2007

NDA

Drug Name

Purpose

Approval Date

NDA 21150/S-007 Zyrtec-D

Antihistamine and

Nasal Decongestant

AP 11-9-07
NDA 22155 Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (solution) Antihistamine AP 11-16-07
NDA 21621/S-005 Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (chewable tablets) Antihistamine AP 11-16-07
NDA 19835/S-022 Zyrtec Allergy and Zyrtec Hives Relief (tablets) Antihistamine AP 11-16-07

2006

NDA

Drug Name

Purpose

Approval Date

NDA 21958 Lamisil Derm Gel Topical Antifungal AP 7-24-06
NDA 21045/S-011 Plan B Emergency Contraceptive AP 8-24-06
NDA 22015 MiraLax Laxative AP 10-6-06
NDA 21066/S-011 Zaditor Antihistamine Eye Drop AP 10-19-06

2005
There are no switches for this period of time.
 
2004
There are no switches for this period of time

2003

NDA

Drug Name

Purpose

Approval Date

NDA 19658/S-020
NDA 20704/S-009
NDA 20641/S-011
Claritin Hives Relief Tablets, Reditabs and Solution Antihistamine AP 11-19-03

2002

NDA

Drug Name

Purpose

Approval Date

NDA 20150/S-011 Nicotrol TD Smoking Cessation AP 3-21-02
NDA 19658/S-018
NDA 20704/S-008
NDA 20641/S-009
Claritin Tablets, Reditabs and Solution Antihistamine AP 11-27-02
NDA 19670/S-018 Claritin-D Antihistamine/Decongestant AP 11-27-02
NDA 20470/S-016 Claritin-D 24-hour Antihistamine/ Decongestant AP 11-27-02

2001

NDA

Drug Name

Purpose

Approval Date

NDA 21307 Lotrimin Ultra Topical Antifungal AP 12-7-01

 1These 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.

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