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FDA Drug Application 012802 by SANDOZ

Application Number012802
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
AP09/5/1961N       
AP010/3/1980SCM       
AP01/17/2003SLR8817014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf 5/28/2004
AP01/17/2003SLR8752016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf 5/27/2004
AP02/6/1992SCM       
AP010/12/1989SCP       
AP01/22/1992SCS       
AP011/5/1992SCS       
AP01/6/1992SCS       
AP09/7/1993SLR       
AP08/4/1994SCS       
AP011/9/1995SCS       
AP010/25/1999SCS       
AP08/29/2001SCS       
AP01/14/2010SLR24545031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf 1/20/2010
AP01/14/2010SLR24637031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012802s031ltr.pdf 1/26/2010
AP09/4/2014SCM       
AP07/3/2014SLR39783033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012802Orig1s033ltr.pdf 7/8/2014
AP07/3/2014SLR39810033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf 7/8/2014




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