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FDA Drug Application 004782 by WYETH PHARMS INC

Application Number004782
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)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/8/1942N22675000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm 6/2/2009
AP01/26/1984SCF       
AP05/29/1985SCP       
AP04/29/1985SLR       
AP05/29/1985SCS       
AP04/29/1985SLR       
AP04/29/1985SLR       
AP05/28/1986SLR       
AP09/30/1985SCS       
AP010/25/1985SCP       
AP01/7/1986SCF       
AP05/19/1989SLR       
AP05/12/1986SCS       
AP07/10/1986SCS       
AP05/19/1989SLR       
AP012/3/1986SCS       
AP09/24/1986SCM       
AP010/16/1987SCS       
AP05/14/1987SCM       
AP04/17/1988SCS       
AP05/19/1989SLR       
AP012/20/1988SCP       
AP02/3/1989SCF       
AP05/19/1989SLR       
AP05/14/1991SCS       
AP05/9/1991SCE       
AP05/19/1989SLR       
AP012/22/1989SLR       
AP02/23/1990SCF       
AP04/26/1999SCS       
AP03/11/1992SCP       
AP012/23/1993SLR       
AP09/8/1998SE23688093   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093.cfm 9/8/1998
AP09/8/1998SE24994093   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093_premarin_appltrs.pdf 9/8/1998
AP011/9/1994SCS       
AP02/6/1995SCM       
AP05/6/1998SLR       
AP04/11/1995SCS       
AP012/13/1995SCS       
AP012/14/1995SCS       
AP02/27/1998SCS       
AP06/27/1996SCS       
AP06/28/1996SCS       
AP05/6/1998SLR       
AP010/29/1998SCS       
AP06/8/1999SLR       
AP07/5/2000SCS       
AP04/24/2003SE25509115   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf 4/28/2003
AP04/24/2003SE25640115   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf 5/16/2003
AP04/24/2003SE216187115   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf 4/9/2007
AP04/24/2001SCE       
AP08/6/2001SCS       
AP012/3/2001SCS       
AP08/21/2002SCS       
AP07/16/2003SLR6177125   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr125ltr.pdf 7/28/2003
AP012/20/2002SCS       
AP011/27/2002SLR3686128   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/04782slr128ltr.pdf 11/27/2002
AP011/27/2002SLR3687128   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf 11/27/2002
AP01/7/2003SLR3684129   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr129ltr.pdf 1/7/2003
AP01/7/2003SLR3685129   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf 1/7/2003
AP04/24/2003SLR5524130   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf 4/30/2003
AP04/24/2003SLR5641130   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf 5/16/2003
AP04/24/2003SLR16188130   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf 4/9/2007
AP04/20/2004SLR8425133   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf 4/29/2004
AP04/20/2004SLR8475133   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf 5/4/2004
AP04/20/2004SLR8424136   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf 4/29/2004
AP04/20/2004SLR10624136   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf 11/17/2004
AP08/26/2004SCF10106137   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782s137ltr.pdf 8/31/2004
AP08/26/2004SCF10107137   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf 8/31/2004
AP04/7/2005SLR11386138   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf 4/12/2005
AP04/7/2005SLR11378138   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf 4/12/2005
AP04/7/2005SLR11379139   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf 4/12/2005
AP04/7/2005SLR11387139   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf 4/12/2005
AP08/1/2005SCF12534141   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf 8/4/2005
AP08/1/2005SCF12541141   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s141ltr.pdf 8/4/2005
AP011/1/2005SCF13014142   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s142ltr.pdf 11/3/2005
AP011/1/2005SCF13017142   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf 11/3/2005
AP04/24/2006SLR13982146   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf 4/25/2006
AP04/24/2006SLR13990146   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/004782s146LTR.pdf 4/25/2006
AP09/5/2006SLR14802147   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf 9/12/2006
AP09/5/2006SLR14851147   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/04782s147_ltr.pdf 9/18/2006
AP03/3/2008SLR19360155   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf 3/5/2008
AP03/3/2008SLR19376155   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/004782s155ltr.pdf 3/5/2008
AP010/28/2011SLR30435162   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf 10/31/2011
AP010/28/2011SLR30450162   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf 11/1/2011
AP04/11/2014SCM       
AP010/28/2011SLR30451164   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf 11/1/2011
AP010/28/2011SLR30436164   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf 10/31/2011
AP010/28/2011SLR30437167   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf 10/31/2011
AP010/28/2011SLR30452167   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf 11/1/2011
AP012/3/2014SLR41154171   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/004782Orig1s171ltr.pdf 12/4/2014
AP012/3/2014SLR41190171   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf 12/10/2014
AP06/9/2015SCM       
AP09/1/2015SCM       




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