Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 004782
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREMARIN | ESTROGENS, CONJUGATED | 1.25MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| PREMARIN | ESTROGENS, CONJUGATED | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| PREMARIN | ESTROGENS, CONJUGATED | 0.3MG | TABLET;ORAL | Prescription | None | Yes | No |
| PREMARIN | ESTROGENS, CONJUGATED | 0.625MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| PREMARIN | ESTROGENS, CONJUGATED | 0.9MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| PREMARIN | ESTROGENS, CONJUGATED | 0.45MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/08/1942 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-181 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/004782s181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/004782Orig1s181ltr.pdf | |
| 11/07/2017 | SUPPL-176 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/004782s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/004782Orig1s176ltr.pdf | |
| 09/01/2015 | SUPPL-173 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/2015 | SUPPL-172 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/2014 | SUPPL-171 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/004782Orig1s171ltr.pdf | |
| 10/28/2011 | SUPPL-167 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf | |
| 10/28/2011 | SUPPL-164 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf | |
| 04/11/2014 | SUPPL-163 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/2011 | SUPPL-162 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf | |
| 03/03/2008 | SUPPL-155 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/004782s155ltr.pdf | |
| 09/05/2006 | SUPPL-147 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/04782s147_ltr.pdf | |
| 04/24/2006 | SUPPL-146 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/004782s146LTR.pdf | |
| 11/01/2005 | SUPPL-142 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s142ltr.pdf | |
| 08/01/2005 | SUPPL-141 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s141ltr.pdf | |
| 04/07/2005 | SUPPL-139 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf | |
| 04/07/2005 | SUPPL-138 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf | |
| 08/26/2004 | SUPPL-137 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782s137ltr.pdf | |
| 04/20/2004 | SUPPL-136 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf | |
| 04/20/2004 | SUPPL-133 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf | |
| 04/24/2003 | SUPPL-130 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf | |
| 01/07/2003 | SUPPL-129 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr129ltr.pdf | |
| 11/27/2002 | SUPPL-128 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/04782slr128ltr.pdf | |
| 12/20/2002 | SUPPL-126 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/2003 | SUPPL-125 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr125ltr.pdf |
| 08/21/2002 | SUPPL-124 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/2001 | SUPPL-121 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/2001 | SUPPL-120 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/2001 | SUPPL-116 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/24/2003 | SUPPL-115 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf | |
| 07/05/2000 | SUPPL-113 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-108 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-104 | Labeling |
Label is not available on this site. |
||
| 06/28/1996 | SUPPL-103 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1996 | SUPPL-102 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1998 | SUPPL-101 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-100 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1995 | SUPPL-99 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/1995 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1994 | SUPPL-94 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-93 | Efficacy-New Dosing Regimen |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093_premarin_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093.cfm |
| 12/23/1993 | SUPPL-92 | Labeling |
Label is not available on this site. |
||
| 03/11/1992 | SUPPL-87 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-86 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1990 | SUPPL-83 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/22/1989 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 05/09/1991 | SUPPL-78 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/14/1991 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 02/03/1989 | SUPPL-74 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/20/1988 | SUPPL-73 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 04/17/1988 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1987 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1987 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1986 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1986 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 01/07/1986 | SUPPL-60 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1985 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1986 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 05/29/1985 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 05/29/1985 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/26/1984 | SUPPL-49 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-181 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/004782s181lbl.pdf | |
| 11/07/2017 | SUPPL-176 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/004782s176lbl.pdf | |
| 12/03/2014 | SUPPL-171 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf | |
| 10/28/2011 | SUPPL-167 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf | |
| 10/28/2011 | SUPPL-164 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf | |
| 10/28/2011 | SUPPL-162 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf | |
| 03/03/2008 | SUPPL-155 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf | |
| 09/05/2006 | SUPPL-147 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf | |
| 04/24/2006 | SUPPL-146 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf | |
| 11/01/2005 | SUPPL-142 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf | |
| 08/01/2005 | SUPPL-141 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf | |
| 04/07/2005 | SUPPL-139 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf | |
| 04/07/2005 | SUPPL-138 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf | |
| 08/26/2004 | SUPPL-137 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf | |
| 04/20/2004 | SUPPL-136 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf | |
| 04/20/2004 | SUPPL-133 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf | |
| 04/24/2003 | SUPPL-130 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf | |
| 04/24/2003 | SUPPL-115 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf | |
| 01/07/2003 | SUPPL-129 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf | |
| 11/27/2002 | SUPPL-128 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf |