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FDA Drug Application 205641 by MERCK SHARP DOHME

Application Number205641
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/25/2014N39186000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205641Orig1s000ltr.pdf 5/1/2014
AP04/25/2014N39292000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205641s000lbl.pdf 5/12/2014
AP04/25/2014N40927000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205641Orig1s000TOC.cfm 11/3/2014
AP04/25/2014N40928000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205641Orig1s000SumR.pdf 11/3/2014
AP08/6/2015SCM       
AP06/16/2015SLR43074002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205641Orig1s002ltr.pdf 6/18/2015
AP06/16/2015SLR43314002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s002lbl.pdf 7/10/2015
AP08/3/2015SCM43565004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s004lbl.pdf 8/4/2015
AP07/12/2016SE846518005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641Orig1s005ltr.pdf 7/13/2016
AP07/12/2016SE846522005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf 7/13/2016




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