Treats advanced prostatic cancer. ANDA 215826, held by Zydus Pharms. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 215826 (Leuprolide Acetate), held by Zydus Pharms, was first approved by FDA on Nov 13, 2025, with 1 approved supplement 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 |
|---|---|---|---|
| Nov 13, 2025 | 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 2Labeling · Standard review | Approved | None posted |
| Nov 13, 2025 | 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
