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FDA Drug Application 011685 by SANDOZ

Application Number011685
Application Type New Drug Application
Sponsor ApplicantSANDOZ
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/12/1959N       
AP010/6/1980SCF       
AP02/6/1992SCM       
AP010/12/1989SCP       
AP011/5/1992SCS       
AP02/6/1992SCS       
AP09/7/1993SLR       
AP08/4/1994SCS       
AP011/9/1995SCS       
AP010/25/1999SCS       
AP08/29/2001SCS       
AP07/3/2014SLR39784026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011685Orig1s026ltr.pdf 7/8/2014
AP07/3/2014SLR39809026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf 7/8/2014




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