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FDA Drug Application 021165 by MERCK SHARP DOHME

Application Number021165
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/21/2001N2472000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-165_Clarinex_Approv.pdf 12/21/2001
AP012/21/2001N2473000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21165lbl.pdf 12/21/2001
AP012/21/2001N2474000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-165_Clarinex.cfm 12/21/2001
AP02/8/2002SLR6117001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex.cfm 7/8/2003
AP02/8/2002SLR8842001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex_Prntlbl.pdf 6/1/2004
AP02/8/2002SLR2471001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21165s1ltr.pdf 2/8/2002
AP01/29/2004SLR7671006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr006ltr.pdf 2/3/2004
AP012/14/2006SLR15537007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/14/2006SLR15538008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/14/2006SLR15536009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/22/2010SLR27405014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf 12/28/2010
AP012/22/2010SLR32612014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf 5/3/2012
AP07/23/2013SCM       
AP04/23/2014SLR39131017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf 4/24/2014
AP04/23/2014SLR39141017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf 4/25/2014
AP06/16/2016SCM       
AP06/16/2016SCM       




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