Application 021443
- Type
- NDA
- Sponsor
- ASPEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | TABLET;ORAL | 0.3MG | No | No |
| 002 | ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | TABLET;ORAL | 0.45MG | No | No |
| 003 | ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | TABLET;ORAL | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 004 | ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 005 | ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | TABLET;ORAL | 0.9MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85029 | SUPPL | 2026-02-12 |
| 85019 | SUPPL | 2026-02-12 |
| 77539 | SUPPL | 2024-02-16 |
| 77523 | SUPPL | 2024-02-16 |
| 65472 | SUPPL | 2020-12-02 |
| 65471 | SUPPL | 2020-12-02 |
| 65447 | SUPPL | 2020-12-01 |
| 65446 | SUPPL | 2020-12-01 |
| 50271 | SUPPL | 2017-11-02 |
| 27793 | SUPPL | 2015-07-09 |
| 36936 | SUPPL | 2015-07-01 |
| 27792 | SUPPL | 2007-05-01 |
| 27791 | SUPPL | 2007-05-01 |
| 15475 | SUPPL | 2007-04-25 |
| 42168 | ORIG | 2006-07-27 |
| 27790 | ORIG | 2004-05-26 |
| 15474 | ORIG | 2004-05-19 |