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FDA Drug Application 017398 by SANDOZ

Application Number017398
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
AP08/14/1973N       
AP011/13/1980SCS       
AP011/13/1980SLR       
AP05/18/1982SCM       
AP05/18/1982SLR       
AP03/5/1999SLR       
AP02/10/1987SCS       
AP03/30/1988SCS       
AP010/5/1990SCM       
AP010/6/1992SCM       
AP02/28/1994SCM       
AP03/4/1997SCS       
AP03/15/1999SCM       
AP07/12/1999SLR       
AP010/17/2003SCM6834014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17398scm014ltr.pdf 10/22/2003
AP09/21/2004SCM10284015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17398s015ltr.pdf 9/29/2004
AP09/21/2004SCM10285015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf 9/29/2004
AP07/22/2013SCM       
AP05/18/2016SCM       




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