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FDA Drug Application 020216 by WYETH PHARMS INC

Application Number020216
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/1978N22677000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm 6/2/2009
AP010/16/1978N27863000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_original_approval.pdf 2/15/2011
AP010/5/1982SC       
AP08/30/1982SC       
AP08/30/1982SC       
AP08/30/1982SC       
AP05/3/1984SC       
AP011/7/1985SC       
AP012/17/1985SC27467018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s018_premarin vaginal cream.pdf 1/7/2011
AP012/17/1985SC       
AP012/17/1985SC       
AP02/12/1988SC       
AP02/12/1988SC       
AP05/10/1990SL27468030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s030_premarin vaginal cream.pdf 1/7/2011
AP06/7/1990SLI       
AP06/14/1993SCF27864033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s033_premarin_vaginal_cream.pdf 2/15/2011
AP010/14/1994SCM       
AP02/6/1995SCM       
AP07/11/1995SLR       
AP08/30/1995SCS       
AP07/11/1995SLR       
AP012/14/1995SCS       
AP012/4/1998SCF       
AP05/8/2002SCM       
AP04/20/2004SLR8398052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020216s052lbl.pdf 4/23/2004
AP04/20/2004SLR8442052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20216slr052ltr.pdf 4/29/2004
AP01/14/2005SLR11010053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf 1/21/2005
AP01/14/2005SLR11011053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020216s053lbl.pdf 1/21/2005
AP08/30/2005SLR12719054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054ltr.pdf 9/7/2005
AP08/30/2005SLR12720054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf 9/7/2005
AP07/26/2006SLR14541055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf 7/27/2006
AP07/26/2006SLR14620055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050, 020216s055LTR.pdf 8/4/2006
AP012/20/2007SLR       
AP03/3/2008SLR19361059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s059lbl.pdf 3/5/2008
AP03/3/2008SLR19378059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s059ltr.pdf 3/5/2008
AP011/7/2008SE121207060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf 11/12/2008
AP011/7/2008SE121221060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s060ltr.pdf 11/13/2008
AP04/22/2011SLR28607067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020216s067ltr.pdf 4/25/2011
AP04/22/2011SLR28610067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020216s067lbl.pdf 4/26/2011
AP02/14/2012SLR31798073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf 2/15/2012
AP02/14/2012SLR31815073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf 2/17/2012
AP02/14/2012SLR31799074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf 2/15/2012
AP02/14/2012SLR31816074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf 2/17/2012
AP02/14/2012SLR31800075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf 2/15/2012
AP02/14/2012SLR31817075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf 2/17/2012
AP09/25/2014SCM       
AP012/28/2015SLR44916081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020216Orig1s081ltr.pdf 12/30/2015
AP012/28/2015SLR44928081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020216s081lbl.pdf 12/31/2015
AP09/15/2016SCM       




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