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FDA Drug Application 021300 by MERCK SHARP DOHME

Application Number021300
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
AP09/1/2004N10113000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21300lbl.pdf 9/3/2004
AP09/1/2004N10123000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21300ltr.pdf 9/3/2004
AP09/1/2004N14528000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021300s000_ClarinexTOC.cfm 7/25/2006
AP012/14/2006SLR15539001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/14/2006SLR15540003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/14/2006SLR15541005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 12/28/2006
AP012/22/2010SLR27406011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf 12/28/2010
AP04/23/2014SLR39132014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf 4/24/2014
AP04/23/2014SLR39140014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf 4/25/2014




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