Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020527
Company: WYETH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREMPHASE 14/14 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG,0.625MG;N/A,5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG;2.5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG;5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.45MG;1.5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.3MG;1.5MG TABLET;ORAL-28 Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/17/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020527s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020527Orig1s065ltr.pdf
05/04/2016 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

08/31/2015 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020527s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020527Orig1s062ltr.pdf
02/25/2016 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

07/01/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/02/2012 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf
02/02/2012 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf
02/02/2012 SUPPL-52 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf
02/02/2012 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf
05/18/2009 SUPPL-46 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020527Orig1s046.pdf
12/30/2009 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s045ltr.pdf
03/03/2008 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020527s043ltr.pdf
07/27/2006 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020527s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020527s037ltr.pdf
06/30/2005 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020527s036ltr.pdf
04/20/2004 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf
04/20/2004 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf
06/04/2003 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s031_prempro.pdf
01/07/2003 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527slr030ltr.pdf
11/27/2002 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20527slr029_prempro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527slr029ltr.pdf
06/04/2003 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s026_prempro.pdf
07/10/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/04/2003 SUPPL-24 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s024_prempro.pdf
12/03/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527s018ltr.pdf
03/12/2003 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020527s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527s017_prempro_toc.cfm
01/06/2000 SUPPL-15 Labeling

Label is not available on this site.

03/18/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1998 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527S013_Prempro.pdf
03/10/1998 SUPPL-9 Labeling

Label is not available on this site.

08/08/1997 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/30/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1998 SUPPL-6 Efficacy-New Dosing Regimen Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20527r.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527se2006_prempro.cfm
01/24/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1997 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20527S004_Prempro.pdf
06/28/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1996 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2017 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020527s065lbl.pdf
08/31/2015 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020527s062lbl.pdf
02/02/2012 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
02/02/2012 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
02/02/2012 SUPPL-52 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
02/02/2012 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
12/30/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s045lbl.pdf
05/18/2009 SUPPL-46 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf
03/03/2008 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf
07/27/2006 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020527s037lbl.pdf
06/30/2005 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf
04/20/2004 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf
04/20/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf
06/04/2003 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf
06/04/2003 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf
06/04/2003 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf
03/12/2003 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020527s017lbl.pdf
01/07/2003 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf
11/27/2002 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20527slr029_prempro_lbl.pdf

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