NDA 21417, held by Wyeth Pharms Inc. Estrogens, Conjugated.
As of Nov 14, 2026, NDA 21417 (Premarin), held by Wyeth Pharms Inc, was first approved by FDA on Jul 16, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2003 | Original applicationTYPE 6 · Standard review | Approved |
| Premarin0.3MG · tablet; oral | Estrogens, Conjugated | Rx |
| Premarin0.45MG · tablet; oral | Estrogens, Conjugated | Rx |
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
