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FDA Drug Application 050750 by WYETH PHARMS INC

Application Number050750
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/24/1998N326000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50750.pdf 2/24/1998
AP07/13/1998SCM       
AP03/27/2002SLR2204003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50750s003ltr.pdf 3/27/2002
AP02/1/2001SCS       
AP03/14/2002SCS       
AP05/6/2003SLR5625007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s007lbl.pdf 5/13/2003
AP05/6/2003SLR5769007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750slr007ltr.pdf 5/30/2003
AP05/6/2003SE25768008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750se2-008ltr.pdf 5/30/2003
AP05/6/2003SE25624008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s008lbl.pdf 5/13/2003
AP03/15/2005SLR11254009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr.pdf 3/18/2005
AP06/27/2005SLR11918011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s044,050750s011ltr.pdf 6/29/2005
AP09/30/2005SCF12847012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf 10/10/2005
AP09/30/2005SCF12918012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s045,050750s012ltr.pdf 10/20/2005
AP09/30/2005SCF16737012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050684_S045_050750_s012_ZosynTOC.cfm 6/11/2007
AP07/26/2006SE814543014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050750s014lbl.pdf 7/27/2006
AP07/26/2006SE814618014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050750s014LTR.pdf 8/4/2006
AP04/17/2008SLR19697015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050750s015ltr.pdf 4/22/2008
AP04/17/2008SLR19933015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050750s015lbl.pdf 6/5/2008
AP05/11/2012SLR32686016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016ltr.pdf 5/15/2012
AP05/11/2012SLR32693016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf 5/15/2012
AP05/11/2012SLR32694020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf 5/15/2012
AP09/6/2013SLR36998021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf 9/9/2013
AP09/6/2013SLR37046021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf 9/11/2013
AP09/28/2011SLR30167024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf 9/30/2011
AP09/28/2011SLR30193024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050684s071,050750s024ltr.pdf 10/3/2011
AP09/6/2013SLR36999026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf 9/9/2013
AP09/6/2013SLR37047026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf 9/11/2013
AP06/18/2013SCM       
AP09/6/2013SLR37048030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf 9/11/2013
AP09/6/2013SLR37000030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf 9/9/2013
AP07/17/2014SCM       
AP06/24/2014SCM       
AP012/18/2015SLR44843033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050684Orig1s083; 050750Orig1s033ltr.pdf 12/22/2015
AP012/18/2015SLR44902033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf 12/29/2015
AP06/10/2016SLR46297034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf 6/13/2016
AP06/10/2016SLR46312034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf 6/13/2016
AP06/10/2016SLR46313035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf 6/13/2016
AP06/10/2016SLR46298035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf 6/13/2016




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