NDA 21443, held by Aspen. Estrogens, Conjugated Synthetic B.
As of Nov 14, 2026, NDA 21443 (Enjuvia), held by Aspen, was first approved by FDA on May 10, 2004, with 8 approved supplements and 0 published complete response letters.
| Apr 23, 2007 | Supplement 4Efficacy (new indication or use) | Approved | |
| May 10, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Enjuvia0.3MG · tablet;oral | Estrogens, Conjugated Synthetic B | Discontinued |
| Enjuvia0.45MG · tablet;oral | Estrogens, Conjugated Synthetic B | Discontinued |
| Enjuvia0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic B | Discontinued |
| Enjuvia1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic B | Discontinued |
| Enjuvia0.9MG · tablet;oral | Estrogens, Conjugated Synthetic B | Discontinued |
| Feb 12, 2026 | Supplement 14Labeling · Standard review | Approved | |
| Feb 15, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Nov 30, 2020 | Supplement 11Labeling · Standard review | Approved | |
| Nov 30, 2020 | Supplement 12Labeling · Standard review | Approved | |
| Nov 1, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Jun 30, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Apr 27, 2007 | Supplement 5Manufacturing | Approved | |
| Apr 23, 2007 | Supplement 4Efficacy (new indication or use) | Approved | |
| May 10, 2004 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
