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FDA Drug Application 021265 by SANDOZ

Application Number021265
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
AP02/21/2001N1894000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_Approv.pdf 2/21/2001
AP02/21/2001N1895000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_prntlbl.pdf 2/21/2001
AP02/21/2001N1896000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite.cfm 2/21/2001
AP010/3/2001SLR5559001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21265s1lbl.pdf 5/2/2003
AP06/26/2001SCS       
AP07/9/2002SCS       
AP07/10/2002SCS       
AP02/12/2003SLR9119005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21265slr005ltr.pdf 6/7/2004
AP012/17/2008SCS21396015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021265s015ltr.pdf 12/23/2008
AP012/17/2008SCS21454015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf 1/2/2009
AP09/4/2014SCM       
AP011/11/2014SCM       
AP03/17/2016SLR45461030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021265Orig1s030,021646Orig1s022ltr.pdf 3/21/2016
AP03/17/2016SLR45466030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021265s030,021646s022lbl.pdf 3/22/2016
AP012/2/2015SCM       




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