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FDA Drug Application 050684 by WYETH PHARMS INC

Application Number050684
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/1993N       
AP05/8/1996SE1       
AP07/13/1994SLR       
AP08/24/1994SCP       
AP07/13/1994SLR       
AP010/12/1994SCS       
AP07/10/1995SCS       
AP012/13/1996SCS       
AP011/18/1996SCP       
AP06/16/1997SCP       
AP07/31/1997SCS       
AP03/11/1999SCM       
AP07/13/1998SCM       
AP03/27/2002SLR2206015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50750s003ltr.pdf 3/27/2002
AP08/1/2000SCP       
AP08/1/2000SCS       
AP08/1/2000SCS       
AP011/21/2000SCS       
AP011/22/2000SCM       
AP02/1/2001SCS       
AP08/20/2001SCP       
AP012/19/2001SCS       
AP02/26/2002SCS       
AP03/14/2002SCS       
AP03/15/2002SCE       
AP03/15/2002SCS       
AP010/10/2002SCS       
AP012/4/2002SCP       
AP04/28/2003SE25525033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s033lbl.pdf 4/30/2003
AP04/28/2003SE25734033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50684se2-033ltr.pdf 5/29/2003
AP05/1/2003SLR5755035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50684slr035ltr.pdf 5/30/2003
AP05/1/2003SLR5581035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s035lbl.pdf 5/6/2003
AP01/30/2004SLR7664038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50684slr038ltr.pdf 2/3/2004
AP03/15/2005SLR11253039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr.pdf 3/18/2005
AP06/27/2005SLR11917044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s044,050750s011ltr.pdf 6/29/2005
AP09/30/2005SCF12848045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf 10/10/2005
AP09/30/2005SCF12917045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s045,050750s012ltr.pdf 10/20/2005
AP09/30/2005SCF16736045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050684_S045_050750_s012_ZosynTOC.cfm 6/11/2007
AP07/26/2006SE814544046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050684s046lbl.pdf 7/27/2006
AP07/26/2006SE814619046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050684s046LTR.pdf 8/4/2006
AP04/17/2008SLR19695051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051, s052ltr.pdf 4/22/2008
AP04/17/2008SLR19927051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf 6/5/2008
AP04/17/2008SLR19928052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf 6/5/2008
AP04/17/2008SLR19696052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051, s052ltr.pdf 4/22/2008
AP05/11/2012SLR32692055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf 5/15/2012
AP05/11/2012SLR32687061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016ltr.pdf 5/15/2012
AP05/11/2012SLR32691061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf 5/15/2012
AP09/6/2013SLR37001063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf 9/9/2013
AP09/6/2013SLR37043063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf 9/11/2013
AP09/28/2011SLR30168071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf 9/30/2011
AP09/28/2011SLR30192071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050684s071,050750s024ltr.pdf 10/3/2011
AP09/6/2013SLR37044074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf 9/11/2013
AP09/6/2013SLR37002074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf 9/9/2013
AP03/27/2013SCM       
AP08/20/2013SCM       
AP09/6/2013SLR37003080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf 9/9/2013
AP09/6/2013SLR37045080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf 9/11/2013
AP02/25/2014SCM       
AP08/5/2014SCM       
AP012/18/2015SLR44842083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050684Orig1s083; 050750Orig1s033ltr.pdf 12/22/2015
AP012/18/2015SLR44901083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf 12/29/2015
AP06/10/2016SLR46295084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf 6/13/2016
AP06/10/2016SLR46314084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf 6/13/2016
AP05/16/2016SCM       
AP06/10/2016SLR46315086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf 6/13/2016
AP06/10/2016SLR46296086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf 6/13/2016
AP09/7/2016SCM       




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