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FDA Drug Application 050741 by STIEFEL

Application Number050741
Application Type New Drug Application
Sponsor ApplicantSTIEFEL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/26/2002N5495000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050741_duac.cfm 4/28/2003
AP08/26/2002N5496000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50741ltr.pdf 4/28/2003
AP08/26/2002N5497000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50741lbl.pdf 4/28/2003
AP010/20/2003SLR6838003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741slr003ltr.pdf 10/24/2003
AP010/20/2003SLR6839003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741slr003_duac_lbl.pdf 10/27/2003
AP011/17/2003SCS6943004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741scs004ltr.pdf 11/25/2003
AP011/17/2003SCS7031004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741scs004_duac_lbl.pdf 12/2/2003
AP07/22/2008SLR20284011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050741s011lbl.pdf 7/23/2008
AP07/22/2008SLR20290011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050741s011ltr.pdf 7/24/2008
AP011/8/2010SLR26917015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050741s015lbl.pdf 11/8/2010
AP011/8/2010SLR26924015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050741s015ltr.pdf 11/10/2010
AP011/14/2012SCM       
AP012/21/2011SLR31226019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050741s019lbl.pdf 12/23/2011
AP012/21/2011SLR31275019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050741s019ltr.pdf 12/28/2011
AP06/7/2013SLR36251020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s020ltr.pdf 6/11/2013
AP012/27/2013SLR38193021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050741s021lbl.pdf 12/30/2013
AP012/27/2013SLR38196021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s021ltr.pdf 12/31/2013
AP05/19/2014SCM       
AP010/15/2014SCM       
AP04/15/2015SLR42538024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050741s024lbl.pdf 4/16/2015
AP04/15/2015SLR42547024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050741Orig1s024ltr.pdf 4/17/2015




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