Treats advanced prostatic cancer. ANDA 217957, held by Ubi. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 217957 (Leuprolide Acetate), held by Ubi, was first approved by FDA on Oct 17, 2024, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leuprolide Acetate14MG/2.8ML (1MG/0.2ML) · solution;subcutaneous | Leuprolide Acetate | Rx |
| May 6, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 30, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 23, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 17, 2024 | 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
