Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010402
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREMARIN | ESTROGENS, CONJUGATED | 25MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/18/1956 | 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-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/010402s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/010402Orig1s073ltr.pdf | |
| 11/01/2017 | SUPPL-68 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010402s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010402Orig1s068ltr.pdf | |
| 04/11/2012 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010402s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010402Orig1s063ltr.pdf | |
| 03/03/2008 | SUPPL-55 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/010402s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/010402s055ltr.pdf | |
| 06/01/2006 | SUPPL-51 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s051LTR.pdf |
| 07/26/2006 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050, 020216s055LTR.pdf | |
| 08/30/2005 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054ltr.pdf | |
| 01/14/2005 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/10402s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf | |
| 04/20/2004 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010402S046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10402slr046ltr.pdf | |
| 10/09/2002 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2002 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1993 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/12/1993 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1989 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/26/1989 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/07/1986 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/11/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-23 | Labeling |
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-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/010402s073lbl.pdf | |
| 11/01/2017 | SUPPL-68 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010402s068lbl.pdf | |
| 04/11/2012 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010402s063lbl.pdf | |
| 03/03/2008 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/010402s055lbl.pdf | |
| 07/26/2006 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf | |
| 08/30/2005 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf | |
| 01/14/2005 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/10402s047lbl.pdf | |
| 04/20/2004 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010402S046lbl.pdf |