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FDA Drug Application 021426 by SANDOZ

Application Number021426
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
AP05/30/2006N14193000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf 5/31/2006
AP05/30/2006N14199000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021426s000LTR.pdf 6/1/2006
AP05/30/2006N16729000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000TOC.cfm 6/11/2007
AP01/16/2008SCF18890002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf 1/18/2008
AP01/16/2008SCF18907002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s002ltr.pdf 1/18/2008
AP01/16/2008SCF34054002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s002.pdf 10/12/2012
AP08/25/2008SCF20663004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s004ltr.pdf 8/25/2008
AP08/25/2008SCF20675004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf 8/26/2008
AP08/25/2008SCF34055004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s004.pdf 10/12/2012
AP03/25/2009SCE22115006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf 3/26/2009
AP03/25/2009SCE22132006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021426s006ltr.pdf 3/27/2009
AP04/23/2010SE125375007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf 4/28/2010
AP04/23/2010SE125414007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf 5/3/2010
AP04/23/2010SE135940007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s007.pdf 5/2/2013
AP04/23/2010SE125374008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf 4/28/2010
AP04/23/2010SE125415008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf 5/3/2010
AP04/23/2010SE136024008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s008.pdf 5/10/2013
AP08/26/2010SE126290015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf 8/27/2010
AP08/26/2010SE126313015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s015ltr.pdf 8/31/2010
AP07/22/2011SE129598017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf 7/25/2011
AP07/22/2011SE129618017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s017ltr.pdf 7/27/2011
AP04/13/2011SLR28543018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s018ltr.pdf 4/15/2011
AP04/13/2011SLR28551018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf 4/15/2011
AP04/4/2013SCM       
AP06/18/2013SCM       
AP08/22/2013SCM       
AP08/29/2014SLR40361028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021426Orig1s028ltr.pdf 9/3/2014
AP08/29/2014SLR40399028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf 9/3/2014
AP07/14/2014SCM       
AP010/20/2016SCM       




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