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FDA Drug Application 019129 by MYLAN PHARMS INC

Application Number019129
Application Type New Drug Application
Sponsor ApplicantMYLAN PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/1984N       
AP05/3/1985SLR       
AP04/1/1985SCP       
AP04/26/1985SCF       
AP05/10/1985SCS       
AP08/16/1985SLR       
AP010/8/1985SCE       
AP05/13/1988SE2       
AP01/27/1986SCS       
AP07/8/1986SLR       
AP04/14/1987SCE       
AP02/9/1990SLR       
AP07/29/1987SCE       
AP08/4/1987SCM       
AP011/13/1987SCM       
AP010/28/1987SCM       
AP02/25/1988SCS       
AP05/13/1988SCM       
AP06/29/1988SLR       
AP07/21/1988SCS       
AP02/6/1989SLR       
AP06/6/1991SCP       
AP07/1/1992SLR       
AP09/12/1996SCM       
AP01/10/1997SLR       
AP07/16/1999SCP       
AP02/2/2001SCS       
AP03/20/2011SLR28321043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019129s043ltr.pdf 3/24/2011
AP03/20/2011SLR28363043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf 3/28/2011
AP05/11/2015SCM       
AP010/13/2016SCM       




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