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FDA Drug Application 019821 by STIEFEL LABS INC

Application Number019821
Application Type New Drug Application
Sponsor ApplicantSTIEFEL LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/28/1996N24081000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089133.pdf 11/20/2009
AP06/5/1997SLR4343001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19821-S001_Soritane.pdf 6/5/1997
AP04/18/2003SLR5502002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf 4/28/2003
AP04/18/2003SLR5712002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf 5/29/2003
AP04/18/2003SLR17067002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019821_S002&S006_SORIATANE_AP.pdf 7/6/2007
AP012/30/1999SCS       
AP01/11/2001SCF       
AP09/12/2002SCS       
AP04/18/2003SLR17068006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019821_S002&S006_SORIATANE_AP.pdf 7/6/2007
AP04/18/2003SLR5711006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf 5/29/2003
AP04/18/2003SLR5501006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf 4/28/2003
AP01/3/2003SCS       
AP03/22/2004SCP8024010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821scp010ltr.pdf 3/24/2004
AP03/22/2004SCP8273010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821scp010_soriatane_lbl.pdf 4/5/2004
AP010/11/2004SLR10416011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s011ltr.pdf 10/15/2004
AP010/11/2004SLR10417011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821s011lbl.pdf 10/15/2004
AP011/4/2004SLR10539012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s012ltr.pdf 11/8/2004
AP010/18/2007SLR18252014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf 10/22/2007
AP010/18/2007SLR18278014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019821s014,s015ltr.pdf 10/22/2007
AP010/18/2007SLR18279015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019821s014,s015ltr.pdf 10/22/2007
AP010/18/2007SLR18253015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf 10/22/2007
AP08/6/2009SLR24783017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019821s017ltr.pdf 2/16/2010
AP011/25/2011SLR30780018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019821s018ltr.pdf 11/28/2011
AP011/25/2011SLR30787018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018lbl.pdf 11/29/2011
AP011/25/2011SLR30788018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018mg.pdf 11/29/2011
AP02/18/2014SLR38538022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf 2/19/2014
AP02/18/2014SLR38543022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s022ltr.pdf 2/20/2014
AP01/30/2014SLR38402023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s023lbl.pdf 1/31/2014
AP01/30/2014SLR38434023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s023ltr.pdf 2/4/2014
AP05/13/2014SLR39305024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf 5/15/2014
AP05/13/2014SLR39319024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s024ltr.pdf 5/19/2014
AP010/28/2014SCM       
AP05/19/2015SLR42875027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf 5/21/2015
AP05/19/2015SLR42878027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019821Orig1s027ltr.pdf 5/22/2015




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