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FDA Drug Application 019968 by RANBAXY

Application Number019968
Application Type New Drug Application
Sponsor ApplicantRANBAXY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/17/1990N       
AP012/31/1991SE2       
AP02/10/1993SCS       
AP011/4/1993SCS       
AP010/27/1993SCS       
AP07/12/1995SCS       
AP09/17/2004SLR10220007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf 9/17/2004
AP09/17/2004SLR10225007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19968s007ltr.pdf 9/17/2004
AP04/2/2012SLR32345011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf 4/2/2012
AP04/2/2012SLR32355011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011ltr.pdf 4/4/2012
AP05/17/2013SCM       




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