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FDA Drug Application 021312 by MERCK SHARP DOHME

Application Number021312
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/26/2002N2469000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21312ltr.pdf 6/26/2002
AP06/26/2002N2470000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21312lbl.pdf 6/26/2002
AP06/26/2002N6896000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-312_Clarinex.cfm 11/6/2003
AP02/6/2003SLR8841002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21312slr002ltr.pdf 6/1/2004
AP01/29/2004SLR7670004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr006ltr.pdf 2/3/2004
AP012/14/2006SLR15499006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021312s006lbl.pdf 12/26/2006
AP012/14/2006SLR15543006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP07/14/2005SCF27875007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021312_s007_clarinex red-tabs.pdf 2/15/2011
AP07/14/2005SCF12031007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021312s007ltr.pdf 7/21/2005
AP07/14/2005SCF12042007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021312s007lbl.pdf 7/21/2005
AP012/14/2006SLR15544008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/14/2006SLR15542009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/22/2010SLR27407011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf 12/28/2010
AP011/14/2012SCM       
AP04/23/2014SLR39133015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf 4/24/2014
AP04/23/2014SLR39139015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf 4/25/2014




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