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FDA Drug Application 125514 by MERCK SHARP DOHME

Application Number125514
Application Type Biologic License Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/4/2014N40411000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf 9/4/2014
AP09/4/2014N40414000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125514Orig1s000ltr.pdf 9/5/2014
AP09/4/2014N40684000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000TOC.cfm 10/2/2014
AP09/4/2014N40685000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000SumR.pdf 10/2/2014
AP09/4/2014N40720000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417493.pdf 10/6/2014
AP06/19/2015S43099003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s003ltr.pdf 6/22/2015
AP06/19/2015S43107003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf 6/23/2015
AP012/18/2015S44815004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf 12/18/2015
AP012/18/2015S44846004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr.pdf 12/22/2015
AP010/2/2015S44111005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s005lbl.pdf 10/2/2015
AP010/2/2015S44116005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s005ltr.pdf 10/6/2015
AP012/18/2015S44847006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr.pdf 12/22/2015
AP012/18/2015S44848006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf 12/18/2015
AP010/24/2016S47469008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf 10/26/2016
AP010/24/2016S47526008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s008s012lbl.pdf 10/31/2016
AP08/5/2016S46735009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s009lbl.pdf 8/5/2016
AP08/5/2016S46748009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s009ltr.pdf 8/9/2016
AP010/24/2016S47431012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf 10/25/2016
AP010/24/2016S47470012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf 10/26/2016




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