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FDA Drug Application 204974 by ALEMBIC PHARMS LTD

Application Number204974
Application Type Abbreviated New Drug Application
Sponsor ApplicantALEMBIC PHARMS LTD
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
TA04/30/2015TA42709000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204974Orig1s000TAltr.pdf 5/4/2015
AP14/28/2016N42709000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204974Orig1s000TAltr.pdf 5/4/2015
TA04/30/2015TA45821000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204974Orig1s000ltr.pdf 5/2/2016
AP14/28/2016N45821000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204974Orig1s000ltr.pdf 5/2/2016
TA04/30/2015TA45838000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204974Orig1s000lbl.pdf 5/3/2016
AP14/28/2016N45838000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204974Orig1s000lbl.pdf 5/3/2016




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