ANDA 210761, held by Sun Pharm. Medroxyprogesterone Acetate.
As of Nov 15, 2026, ANDA 210761 (Medroxyprogesterone Acetate), held by Sun Pharm, was first approved by FDA on Apr 24, 2019, with 2 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 |
|---|---|---|---|
| Apr 24, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Medroxyprogesterone Acetate150MG/ML · injectable;injection | Medroxyprogesterone Acetate | Discontinued |
| Jun 22, 2021 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 22, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 24, 2019 | 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
