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FDA Drug Application 021163 by SANDOZ

Application Number021163
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
AP05/18/2000N1372000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21163ltr.pdf 5/18/2000
AP05/18/2000N1373000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21163lbl.pdf 5/18/2000
AP05/18/2000N8093000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-163_Multi-12.cfm 3/28/2004
AP06/13/2001SCF       
AP06/26/2001SCM       
AP07/9/2002SCS       
AP02/12/2003SLR9117005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21163slr005ltr.pdf 6/7/2004
AP09/17/2004SLR10221011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21163s011lbl.pdf 9/17/2004
AP09/17/2004SLR10227011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21163s011ltr.pdf 9/17/2004
AP012/5/2008SCS21339016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021163s016ltr.pdf 12/11/2008
AP09/4/2013SCM       
AP07/13/2013SCM       
AP012/3/2013SCM       
AP09/4/2014SCM       
AP010/2/2015SCM       
AP010/26/2015SCM       
AP03/17/2016SLR45468032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021163s032,021559s025lbl.pdf 3/22/2016




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