Application 010402
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREMARIN | ESTROGENS, CONJUGATED | INJECTABLE;INJECTION | 25MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0046-0749 | Premarin | CONJUGATED ESTROGENS | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0749 | Premarin | CONJUGATED ESTROGENS | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0749 | Premarin | CONJUGATED ESTROGENS | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0749 | Premarin | CONJUGATED ESTROGENS | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-0749 | Premarin | CONJUGATED ESTROGENS | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77560 | SUPPL | 2024-02-20 |
| 77513 | SUPPL | 2024-02-16 |
| 50305 | SUPPL | 2017-11-06 |
| 50283 | SUPPL | 2017-11-03 |
| 10750 | SUPPL | 2012-04-17 |
| 11902 | SUPPL | 2012-04-13 |
| 23529 | ORIG | 2009-06-02 |
| 33020 | SUPPL | 2008-03-05 |
| 221 | SUPPL | 2008-03-04 |
| 11901 | SUPPL | 2006-08-04 |
| 33019 | SUPPL | 2006-07-27 |
| 220 | SUPPL | 2006-06-06 |
| 33018 | SUPPL | 2005-09-07 |
| 11900 | SUPPL | 2005-09-07 |
| 33017 | SUPPL | 2005-01-21 |
| 11899 | SUPPL | 2005-01-21 |
| 219 | SUPPL | 2004-04-29 |
| 10749 | SUPPL | 2004-04-23 |