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FDA Drug Application 050577 by TEVA PHARMS USA

Application Number050577
Application Type New Drug Application
Sponsor ApplicantTEVA PHARMS USA
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
AP05/7/1982N       
AP011/17/1986SLR       
AP04/22/1988SLR       
AP08/11/1994SCS       
AP06/14/1993SCS       
AP09/27/1994SCM       
AP06/29/1995SCS       
AP05/5/1999SLR       
AP012/30/2002SLR6212014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf 7/30/2003
AP04/3/2000SCS       
AP01/22/2003SLR4843016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf 1/22/2003
AP010/22/2002SCS       
AP012/4/2012SCM       
AP012/4/2012SCM       
AP012/4/2012SCM       
AP08/9/2013SCM       
AP012/12/2012SCM       
AP07/31/2014SCM       
AP09/23/2014SCM       
AP01/5/2015SCM       
AP01/5/2015SCM       




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