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FDA Drug Application 018782 by TEVA BRANDED PHARM

Application Number018782
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/21/1982N       
AP012/3/1982SLR       
AP03/12/1985SCM       
AP07/25/1984SLR       
AP09/4/1984SCM       
AP07/29/1985SCS       
AP09/6/1985SLR       
AP02/19/1986SCS       
AP012/20/1985SLR       
AP012/27/1996SCS       
AP07/15/1986SLR       
AP08/8/1990SLR       
AP04/27/1988SCE       
AP05/19/1989SCM       
AP05/20/1991SCM       
AP05/3/1991SCM       
AP06/10/1992SCS       
AP01/28/1994SLR       
AP011/29/1994SLR       
AP04/8/1994SCM       
AP010/11/1995SCS       
AP05/17/1996SCM       
AP04/3/2000SLR3450023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf 2/5/2003
AP03/11/1998SCM       
AP012/11/1998SCM       
AP03/6/2002SCM       
AP06/3/2013N36195036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018782s036lbl.pdf 6/3/2013
AP06/3/2013N36204036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018782Orig1s036ltr.pdf 6/4/2013




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