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FDA Drug Application 205776 by MEDAC PHARMA INC

Application Number205776
Application Type New Drug Application
Sponsor ApplicantMEDAC PHARMA INC
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
AP07/10/2014N39843000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s000lbl.pdf 7/11/2014
AP07/10/2014N39846000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205776Orig1s000ltr.pdf 7/11/2014
AP07/10/2014N42499000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205776Orig1s000TOC.cfm 4/13/2015
AP08/24/2015SLR43706001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205776Orig1s001ltr.pdf 8/25/2015
AP08/24/2015SLR43708001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205776s001lbl.pdf 8/25/2015




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