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FDA Drug Application 021204 by NOVARTIS

Application Number021204
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/2000N1434000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21204ltr.pdf 12/22/2000
AP012/22/2000N1435000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21204lbl.pdf 12/22/2000
AP012/22/2000N3311000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-204_Stsrlix.cfm 3/18/2002
AP05/1/2001SCS       
AP01/3/2002SCM       
AP02/27/2002SCM       
AP09/25/2002SCS       
AP011/26/2002SLR3309005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21204slr005ltr.pdf 11/26/2002
AP011/26/2002SLR3310005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21204slr005_Starlix_lbl.pdf 11/26/2002
AP010/20/2003SE16836006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21204se1-006ltr.pdf 10/27/2003
AP010/20/2003SE16837006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21204se1-006_starlix_lbl.pdf 10/27/2003
AP010/20/2003SE117038006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021204_S006_STARLIX_TABS_AP.pdf 7/6/2007
AP07/1/2004SLR9711009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21204slr009ltr.pdf 7/6/2004
AP07/1/2004SLR9717009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21204slr009_starlix_lbl.pdf 7/7/2004
AP011/9/2006SLR15339010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021204s010lbl.pdf 11/13/2006
AP011/9/2006SLR15353010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021204s010LTR.pdf 11/14/2006
AP07/15/2008SLR20213011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021204s011lbl.pdf 7/16/2008
AP07/15/2008SLR20224011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021204s011ltr.pdf 7/17/2008
AP08/24/2011SLR29894014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021204s014ltr.pdf 8/26/2011
AP08/24/2011SLR29904014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021204s014lbl.pdf 8/26/2011
AP012/2/2015SCM       
AP04/7/2016SCM       




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