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FDA Drug Application 021559 by SANDOZ

Application Number021559
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
AP06/16/2003N5979000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21559ltr.pdf 6/22/2003
AP06/16/2003N5983000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21559_infuvite_lbl.pdf 6/22/2003
AP06/16/2003N9959000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-559_Infuvite.cfm 8/9/2004
AP07/13/2004SCS9763005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21559s005ltr.pdf 7/21/2004
AP01/15/2009SCS21646009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021559s009lbl.pdf 1/16/2009
AP01/15/2009SCS21664009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021559s009ltr.pdf 1/21/2009
AP012/4/2012SLR34547015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021559s015lbl.pdf 12/5/2012
AP012/4/2012SLR34559015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021559Orig1s015ltr.pdf 12/5/2012
AP05/29/2013SCM       
AP01/23/2014SCM       
AP09/4/2014SCM       
AP05/23/2016SCM       
AP03/17/2016SLR45463025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021163Orig1s032,021559Orig1s025ltr.pdf 3/21/2016
AP03/17/2016SLR45469025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021163s032,021559s025lbl.pdf 3/22/2016




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