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FDA Drug Application 204286 by MERZ PHARMS

Application Number204286
Application Type New Drug Application
Sponsor ApplicantMERZ PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/27/2013N36402000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204286Orig1s000ltr.pdf 7/1/2013
AP06/27/2013N36534000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204286s000lbl.pdf 7/11/2013
AP06/27/2013N37314000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286_naftin_toc.cfm 10/3/2013
AP06/27/2013N37315000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286Orig1s000SumR.pdf 10/3/2013
AP010/10/2014S40764001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s001ltr.pdf 10/14/2014
AP010/10/2014S40789001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204286s001lbl.pdf 10/15/2014
AP09/24/2014SCM40600002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s002ltr.pdf 9/25/2014




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