ANDA 212824, held by Eugia Pharma. Medroxyprogesterone Acetate.
As of Nov 15, 2026, ANDA 212824 (Medroxyprogesterone Acetate), held by Eugia Pharma, was first approved by FDA on Aug 22, 2022, with 0 approved supplements 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 |
|---|---|---|---|
| Aug 22, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Medroxyprogesterone Acetate150MG/ML · injectable;injection | Medroxyprogesterone Acetate | 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
