Back to FDA Applications sponsored by ASTRAZENECA PHARMS

FDA Drug Application 205060 by ASTRAZENECA PHARMS

Application Number205060
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA 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
AP05/5/2014N39223000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf 5/6/2014
AP05/5/2014N39226000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205060Orig1s000ltr.pdf 5/6/2014
AP05/5/2014N45513000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205060Orig1EpanovaTOC.cfm 3/28/2016
AP05/27/2016SCM       
AP010/7/2016SLR47331002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s002ltr.pdf 10/12/2016
AP010/7/2016SLR47338002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205060s002lbl.pdf 10/12/2016




Back to FDA Applications sponsored by ASTRAZENECA PHARMS