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FDA Drug Application 204536 by AMNEAL PHARMS

Application Number204536
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
TA05/27/2015TA42934000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000TAltr.pdf 5/28/2015
TA05/27/2015TA44849000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000ltr.pdf 12/22/2015
AP112/21/2015N42934000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000TAltr.pdf 5/28/2015
AP112/21/2015N44849000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000ltr.pdf 12/22/2015




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