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`About the Center for Drug Evaluation and Research> Prescripti on to Over-the-Counter (OTC ) SWitch Ust
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Prescription to Over-the-Counter (OTC)
`Switch List
`
`January 1 through March 31, 2016
`There are no switches for this period of time.
`
`January 1 through December 31, 2015
`
`NDA
`
`Drug Name
`
`Purpose
`
`Approval Date
`
`NDA 20476/S-032
`
`Rhinocort Allergy Spray (budesonide)
`
`Allergic rhinitis
`
`AP 3-23-15
`
`January 1 through December 31, 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 7-23-1 4
`
`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
`
`N DA 20872/S-023
`NDA 201-373
`NDA 21-909/S-003
`
`Allegra
`
`Antihistamine
`
`AP 1-25-11
`
`http:/fwww.fda.gov/AboutFDA/CentersOffices/OfficeofM edical ProductsandTobacco/CDER/ucm 1 06378.htm
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`PTX0407
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`MEDA_APTX03502994
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`PTX0407 -00001
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`1
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`CIP2077
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`

`

`6/2812016
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`About the Center for Drug Evaluation and Research> Prescripti on to Over-the-Counter (OTC ) SWitch Ust
`
`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
`
`NDA 22-281 2
`
`Zegerid OTC
`
`Acid reducer/PPI
`
`AP 5-18-09
`
`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
`
`NDA 21-8872
`
`alii
`
`NDA 21-150/S-
`007
`
`Zyrtec-D
`
`Purpose
`
`Approval
`Date
`
`Weight Loss Aid
`
`AP 2-7-07
`
`AP 11-9-07
`
`Antihistamine
`and
`
`Nasal
`Decongestant
`
`NDA 22-155
`
`Children's Zyrtec Allergy and Children's Zyrtec Hives Relief (syrup)
`
`Antihistamine
`
`AP 11-1 6-07
`
`NDA 21-621 /S-
`005
`
`Children's Zyrtec Allergy and Children's Zyrtec Hives Relief
`(chewable tablets )
`
`Antihistamine
`
`AP 11-16-07
`
`N DA 1 9-835/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
`
`NDA 21-045
`
`Plan B
`
`Emergency Contraceptive
`
`NDA 22-015
`
`MiraLax
`
`Laxative
`
`NDA 21-066
`
`Zaditor
`
`Antihistamine Eye Drop
`
`NDA 21-996
`
`AI away
`
`Antihistamine Eye Drop
`
`AP 7-24-06
`
`AP 8-24-06
`
`AP 10-6-06
`
`AP 10-19-06
`
`AP 12-1-06
`
`http:/fwww.fda.gov/AboutFDA/CentersOffices/OfficeofM edical ProductsandTobacco/CDER/ucm 1 06378.htm
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`6/2812016
`
`About the Center for Drug Evaluation and Research> Prescription to Over-the-Counter (OTC) SWitch Ust
`
`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 OM 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
`
`N DA 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
`
`Nicotra! TO
`
`Smoking Cessation
`
`AP 3-21-02
`
`NDA 21-2821
`
`Mucinex ER Tablet
`
`Expectorant
`
`N DA 19-658/S-018
`NDA 20-704/S-008
`NDA 20-641/S-009
`
`Claritin Tablets , Reditabs and Syrup
`
`Antihistamine
`
`AP 7-12-02
`
`AP 11-27-02
`
`N DA 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
`
`NDA 21-307
`
`Lotrimin Ultra
`
`Topical Antifungal
`
`AP 6-29-01
`
`AP 12-7-01
`
`http:/fwww.fda.gov/AboutFDA/CentersOffices/OfficeofM edical ProductsandTobacco/CDER/ucm 1 06378.htm
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`

`6128/2016
`
`About the Center for Drug Evaluation and Research> Prescripti on to Over-the-Counter (OTC) SWitch Ust
`
`__ 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 .
`
`Resources for You
`
`• Over-the-Counter fOTCl Related Federal Register Notices, Ingredient References, and other Regulatory
`Information (I Abo utFDA/CentersOffi ces/Offi ceofM ed i cal Prod uctsand Tobacco/CDE Rlu cm1 06368. html
`
`More in About the Center for Drug Evaluation and Research
`(!AboutFDA/CentersOffices/OfficeofMedicaiProductsandTobacco/CDERidefault.htm)
`
`COER Offices and Divisions (!AboutFDA/CentersOffices/OfficeofMedicaiProductsandTobacco/CDERiucm075128.htm)
`
`Drug Safety Oversight Board
`(I AboutFDAICentersOffi ces/OfficeofMedi cal P roductsandTobacco/CDE Rlucm082129. html
`
`Jobs at the Center for Drug Evaluation and Research (COER)
`(!AboutFDAICenters0ffices/OfficeofMedicaiProductsandTobacco/CDERiucm081244.html
`
`Meeting Presentations (Drugs)
`(/AboutFDAICentersOffices/OfficeotMedicaiProductsandTobacco/CDERiucm074833.html
`
`CDE R Exclusivity Board (I AboutFDA/CentersOfficesiOffi ceotM edi cal Prod uctsandTobacco/CDE Rlu cm323412. htm)
`
`FAQs about COER
`(!AboutFDAICentersOffices/OfficeotMedicaiProductsandTobaccoiCDERIFAQsaboutCDERidefault.htm)
`
`Reports & Budgets (COER)
`(I About F DA/CentersOffices/OfficeofM edical Prod uctsandTobacco/COE R!Report sB udgets/default. htm l
`
`Manual of Policies & Procedures (COER)
`(I AboutFDAICentersOffi ces/Offi ceofM ed i cal Prod u ctsan dTo bacco/CDE RIM an ualofP ol ici esP raced u res/default. htm)
`
`Contact CDE R (! AboutFDA/CentersOffices/OfficeofM edicaiP roductsandTobacco/CDE R!ContactCDE R/default. html
`
`v
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`v
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