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FDA Drug Application 202101 by ALEMBIC PHARMS LTD

Application Number202101
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
TA04/9/2013TA42699000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202101Orig1s000ltr.pdf 4/29/2015
AP14/28/2015N42699000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202101Orig1s000ltr.pdf 4/29/2015
TA04/9/2013TA42705000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202101s000lbl.pdf 4/29/2015
AP14/28/2015N42705000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202101s000lbl.pdf 4/29/2015




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