Treats advanced prostatic cancer. ANDA 213829, held by Somerset Theraps LLC. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 213829 (Leuprolide Acetate), held by Somerset Theraps LLC, was first approved by FDA on Aug 13, 2021, 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 |
|---|---|---|---|
| Aug 13, 2021 | 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 6Labeling · Standard review | Approved | None posted |
| Apr 30, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 23, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 13, 2021 | 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
