Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020216
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREMARIN | ESTROGENS, CONJUGATED | 0.625MG/GM | CREAM;TOPICAL, VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/1978 | ORIG-1 | Approval | UNKNOWN |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_original_approval.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020216s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020216Orig1s091ltr.pdf | |
| 11/01/2017 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020216s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020216Orig1s083ltr.pdf | |
| 12/28/2015 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020216s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020216Orig1s081ltr.pdf | |
| 09/25/2014 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2012 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf | |
| 02/14/2012 | SUPPL-74 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf | |
| 02/14/2012 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf | |
| 01/13/2010 | SUPPL-69 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2011 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020216s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020216s067ltr.pdf | |
| 11/07/2008 | SUPPL-60 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020216Orig1s060.pdf | |
| 03/03/2008 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s059ltr.pdf | |
| 12/20/2007 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 07/26/2006 | SUPPL-55 | 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-54 | 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-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020216s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf | |
| 04/20/2004 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020216s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20216slr052ltr.pdf | |
| 05/08/2002 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1998 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1993 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s033_premarin_vaginal_cream.pdf |
| 06/07/1990 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/10/1990 | SUPPL-30 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s030_premarin vaginal cream.pdf |
| 02/12/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1985 | SUPPL-18 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s018_premarin vaginal cream.pdf |
| 11/07/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1982 | SUPPL-6 | Manufacturing (CMC) |
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-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020216s091lbl.pdf | |
| 11/01/2017 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020216s083lbl.pdf | |
| 12/28/2015 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020216s081lbl.pdf | |
| 02/14/2012 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf | |
| 02/14/2012 | SUPPL-74 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf | |
| 02/14/2012 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf | |
| 04/22/2011 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020216s067lbl.pdf | |
| 11/07/2008 | SUPPL-60 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf | |
| 03/03/2008 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s059lbl.pdf | |
| 07/26/2006 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf | |
| 08/30/2005 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf | |
| 01/14/2005 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020216s053lbl.pdf | |
| 04/20/2004 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020216s052lbl.pdf |