Application 020216
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREMARIN | ESTROGENS, CONJUGATED | CREAM;TOPICAL, VAGINAL | 0.625MG/GM | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0046-0872 | Premarin | conjugated estrogens | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0872 | Premarin | conjugated estrogens | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0872 | Premarin | conjugated estrogens | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0872 | Premarin | conjugated estrogens | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82081 | SUPPL | 2025-05-01 |
| 81983 | SUPPL | 2025-04-24 |
| 80157 | SUPPL | 2024-11-05 |
| 77570 | SUPPL | 2024-02-20 |
| 77547 | SUPPL | 2024-02-16 |
| 65838 | SUPPL | 2021-01-07 |
| 50303 | SUPPL | 2017-11-06 |
| 50282 | SUPPL | 2017-11-03 |
| 34384 | SUPPL | 2015-12-31 |
| 2179 | SUPPL | 2015-12-30 |
| 34383 | SUPPL | 2012-02-17 |
| 12325 | SUPPL | 2012-02-17 |
| 12324 | SUPPL | 2012-02-17 |
| 24590 | SUPPL | 2012-02-15 |
| 24589 | SUPPL | 2012-02-15 |
| 2178 | SUPPL | 2012-02-15 |
| 34382 | SUPPL | 2011-04-26 |
| 24588 | SUPPL | 2011-04-25 |
| 41217 | ORIG | 2011-02-15 |
| 20539 | SUPPL | 2011-02-15 |
| 20538 | SUPPL | 2011-01-07 |
| 20537 | SUPPL | 2011-01-07 |
| 2177 | SUPPL | 2008-11-13 |
| 12323 | SUPPL | 2008-11-12 |
| 34381 | SUPPL | 2008-03-05 |
| 2176 | SUPPL | 2008-03-05 |
| 2175 | SUPPL | 2006-08-04 |
| 34380 | SUPPL | 2006-07-27 |
| 12322 | SUPPL | 2005-09-07 |
| 2174 | SUPPL | 2005-09-07 |
| 34379 | SUPPL | 2005-01-21 |
| 24587 | SUPPL | 2005-01-21 |
| 24586 | SUPPL | 2004-04-29 |
| 34378 | SUPPL | 2004-04-23 |