NDA 21609, held by Duramed. Estrogens, Conjugated Synthetic B.
As of Nov 14, 2026, NDA 21609 (Enjuvia), held by Duramed, was first approved by FDA on Dec 20, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2004 | Original applicationTYPE 6 · Standard review | Approved |
| Enjuvia0.3MG · tablet; oral | Estrogens, Conjugated Synthetic B | Discontinued |
| Enjuvia0.45MG · tablet; oral | Estrogens, Conjugated Synthetic B | Discontinued |
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