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FDA Drug Application 204426 by APIL

Application Number204426
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP04/19/2013N35792000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204426s000lbl.pdf 4/23/2013
AP04/19/2013N35831000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204426Orig1s000ltr.pdf 4/24/2013
AP04/19/2013N37223000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426_minastrin_toc.cfm 9/26/2013
AP04/19/2013N37224000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426Orig1s000SumR.pdf 9/26/2013
AP07/22/2015SCM43481001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204426s001lbl.pdf 7/24/2015
AP08/19/2016SLR46850004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204426Orig1s004ltr.pdf 8/23/2016
AP08/19/2016SLR46861004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204426s004lbl.pdf 8/23/2016




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