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FDA Drug Application 020136 by MEDA PHARMS

Application Number020136
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
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
AP08/23/1993N       
AP09/5/1995SLR       
AP08/9/1995SCM       
AP05/12/1995SCS       
AP02/14/1996SCM       
AP011/15/1995SCM       
AP010/24/1995SCS       
AP011/1/1995SCS       
AP011/30/1995SCS       
AP09/9/1997SE14277009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020136ap_s08_s09.pdf 10/9/1997
AP010/30/1996SCS       
AP02/13/1998SLR       
AP05/30/1997SCS       
AP010/1/1997SCS       
AP011/26/1997SCM       
AP01/7/1998SCS       
AP03/16/1998SCM       
AP04/20/1998SCM       
AP09/17/2002SCP       
AP01/27/2010SLR24668023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020136s023lbl.pdf 1/29/2010
AP01/27/2010SLR24689023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020136s023ltr.pdf 2/1/2010
AP08/14/2012SLR33452024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020136Orig1s024ltr.pdf 8/15/2012
AP08/14/2012SLR33477024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020136s014lbl.pdf 8/15/2012
AP011/16/2012SCM       
AP011/22/2013SCM       




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