ANDA 77334, held by Amphastar Pharms Inc. Medroxyprogesterone Acetate.
As of Nov 15, 2026, ANDA 77334 (Medroxyprogesterone Acetate), held by Amphastar Pharms Inc, was first approved by FDA on Nov 28, 2017, with 1 approved supplement and 0 published complete response letters.
Medroxyprogesterone acetate is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of Medroxyprogesterone acetate 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 |
|---|---|---|---|
| Nov 28, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Medroxyprogesterone Acetate150MG/ML · injectable;injection | Medroxyprogesterone Acetate | Rx |
| Jan 25, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 28, 2017 | 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
