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FDA Drug Application 008678 by SANDOZ

Application Number008678
Application Type New Drug Application
Sponsor ApplicantSANDOZ
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
AP011/17/1952N       
AP09/30/1980SCS       
AP03/28/1983SCS       
AP03/28/1983SCS       
AP08/19/1983SCS       
AP08/19/1983SCS       
AP01/4/1984SCS       
AP09/10/1987SLR       
AP05/9/1985SCM       
AP09/23/1988SCM       
AP08/10/1992SCM       
AP08/10/1992SCM       
AP08/1/1996SLR       
AP011/21/1995SCP       
AP03/6/1997SLR       
AP02/7/2000SCM       
AP07/13/2000SCM       
AP04/23/2007SLR16426025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf 5/1/2007
AP04/23/2007SLR16427026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf 5/1/2007
AP07/13/2016SLR46531028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008678Orig1s028ltr.pdf 7/14/2016
AP07/13/2016SLR46574028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf 7/21/2016




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