ANDA 214293, held by Amneal Pharms. Estradiol; Progesterone.
As of Nov 15, 2026, ANDA 214293 (Estradiol And Progesterone), held by Amneal Pharms, was first approved by FDA on May 16, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Estradiol And Progesterone1MG;100MG · capsule;oral | Estradiol; Progesterone | Discontinued |
| Sep 28, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 16, 2022 | Original application | 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
