Back to FDA Applications sponsored by AMNEAL PHARMS

FDA Drug Application 204839 by AMNEAL PHARMS

Application Number204839
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
TA04/17/2015TA45812000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204839s000lbl.pdf 4/29/2016
AP14/28/2016N45812000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204839s000lbl.pdf 4/29/2016
TA04/17/2015TA45823000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204839Orig1s000ltr.pdf 5/2/2016
AP14/28/2016N45823000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204839Orig1s000ltr.pdf 5/2/2016
TA04/17/2015TA46051000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501649.pdf 5/18/2016
AP14/28/2016N46051000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501649.pdf 5/18/2016




Back to FDA Applications sponsored by AMNEAL PHARMS