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) |
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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