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FDA Drug Application 020527 by WYETH PHARMS INC

Application Number020527
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
AP011/17/1995N22679000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm 6/2/2009
AP012/18/1996SCS       
AP06/27/1996SCS       
AP06/28/1996SCS       
AP07/31/1997SLR4322004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20527S004_Prempro.pdf 7/31/1997
AP01/24/1997SCS       
AP01/9/1998SE2354006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20527r.pdf 1/9/1998
AP01/9/1998SE2355006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527se2006_prempro.cfm 1/9/1998
AP06/30/1997SCS       
AP08/8/1997SCE       
AP03/10/1998SLR       
AP05/12/1998SLR844013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527S013_Prempro.pdf 5/12/1998
AP03/18/1999SCS       
AP01/6/2000SLR       
AP03/12/2003SE24368017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527s017ltr.pdf 3/18/2003
AP03/12/2003SE24442017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020527s017lbl.pdf 3/20/2003
AP03/12/2003SE26628017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527s017_prempro_toc.cfm 9/11/2003
AP02/11/2002SLR3693018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527s018ltr.pdf 2/11/2002
AP012/3/2001SCS       
AP06/4/2003SE15814024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf 6/8/2003
AP06/4/2003SE15883024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf 6/8/2003
AP06/4/2003SE127469024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s024_prempro.pdf 1/7/2011
AP07/10/2002SCM       
AP06/4/2003SLR5815026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf 6/8/2003
AP06/4/2003SLR5886026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf 6/8/2003
AP06/4/2003SLR27472026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s026_prempro.pdf 1/7/2011
AP011/27/2002SLR3691029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527slr029ltr.pdf 11/27/2002
AP011/27/2002SLR3692029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20527slr029_prempro_lbl.pdf 11/27/2002
AP01/7/2003SLR3689030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527slr030ltr.pdf 1/7/2003
AP01/7/2003SLR3690030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf 1/7/2003
AP06/4/2003SLR5816031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf 6/8/2003
AP06/4/2003SLR5887031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf 6/8/2003
AP06/4/2003SLR27473031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s031_prempro.pdf 1/7/2011
AP04/20/2004SLR8397034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf 4/23/2004
AP04/20/2004SLR8445034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf 4/29/2004
AP04/20/2004SLR8446035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf 4/29/2004
AP04/20/2004SLR10801035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf 12/29/2004
AP06/30/2005SLR11934036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf 7/7/2005
AP06/30/2005SLR11948036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020527s036ltr.pdf 7/8/2005
AP07/27/2006SLR14582037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020527s037lbl.pdf 8/4/2006
AP07/27/2006SLR14615037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020527s037ltr.pdf 8/4/2006
AP03/3/2008SLR19362043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf 3/5/2008
AP03/3/2008SLR19377043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020527s043ltr.pdf 3/5/2008
AP012/30/2009SLR24407045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s045lbl.pdf 1/4/2010
AP012/30/2009SLR24446045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s045ltr.pdf 1/6/2010
AP05/18/2009SCF22625046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s046ltr.pdf 5/26/2009
AP05/18/2009SCF22702046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf 6/5/2009
AP05/18/2009SCF34975046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020527Orig1s046.pdf 1/24/2013
AP02/2/2012SLR31681051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf 2/6/2012
AP02/2/2012SLR31699051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf 2/7/2012
AP02/2/2012SCM31682052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf 2/6/2012
AP02/2/2012SCM31700052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf 2/7/2012
AP02/2/2012SLR31683054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf 2/6/2012
AP02/2/2012SLR31701054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf 2/7/2012
AP02/2/2012SLR31684056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf 2/6/2012
AP02/2/2012SLR31702056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf 2/7/2012
AP07/1/2014SCM       
AP02/25/2016SCM       
AP08/31/2015SLR43795062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020527Orig1s062ltr.pdf 9/4/2015
AP08/31/2015SLR43811062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020527s062lbl.pdf 9/4/2015
AP05/4/2016SCM       




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