ANDA 215397, held by Amneal. Medroxyprogesterone Acetate.
As of Nov 15, 2026, ANDA 215397 (Medroxyprogesterone Acetate), held by Amneal, was first approved by FDA on Jun 7, 2023, with 1 approved supplement and 0 published complete response letters.
Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e. longer than 2 years) birth control method unless other options are considered inadequate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Medroxyprogesterone Acetate150MG/ML · injectable;injection | Medroxyprogesterone Acetate | Rx |
| Mar 13, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 7, 2023 | Original application | Approved | None posted |
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
