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FDA Drug Application 088617 by PLIVA

Application Number088617
Application Type Abbreviated New Drug Application
Sponsor ApplicantPLIVA
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
AP01/10/1986N       
AP04/10/1986SC       
AP02/7/1986SC       
AP08/1/1986SC       
AP01/14/1991SL       
AP05/24/1994SL       
AP05/11/1994SC       
AP02/6/1998SC       
AP02/6/1998SC       
AP07/7/2000SCB       
AP01/30/2002SL       
AP08/5/2008SLR39096030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf 4/18/2014
AP06/5/2014SLR39504043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044ltr.pdf 6/11/2014
AP06/5/2014SLR39653043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf 6/24/2014




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