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FDA Drug Application 204857 by AMNEAL PHARMS

Application Number204857
Application Type Abbreviated New Drug Application
Sponsor ApplicantAMNEAL PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA04/30/2015TA42710000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204857Orig1s000TAltr.pdf 5/4/2015
AP19/9/2016N42710000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204857Orig1s000TAltr.pdf 5/4/2015
TA04/30/2015TA47051000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204857Orig1s000ltr.pdf 9/15/2016
AP19/9/2016N47051000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204857Orig1s000ltr.pdf 9/15/2016




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