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Application 021633
- Type
- NDA
- Sponsor
- APIL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FEMTRACE | ESTRADIOL ACETATE | TABLET;ORAL | 0.45MG | Yes | No |
| 002 | FEMTRACE | ESTRADIOL ACETATE | TABLET;ORAL | 0.9MG | Yes | No |
| 003 | FEMTRACE | ESTRADIOL ACETATE | TABLET;ORAL | 1.8MG | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50288 | SUPPL | 2017-11-03 |
| 5894 | SUPPL | 2014-08-14 |
| 15904 | SUPPL | 2014-08-13 |
| 42244 | ORIG | 2005-12-01 |
| 5893 | ORIG | 2004-08-25 |