Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020527
Company: WYETH PHARMS
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 |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020527s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020527Orig1s068ltr.pdf | |
| 04/22/2025 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020527s067lbl.pdf | |
| 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.html | |
| 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.html |
| 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 |
|---|---|---|---|---|---|
| 04/22/2025 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020527s067lbl.pdf | |
| 02/15/2024 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020527s068lbl.pdf | |
| 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 |