Treats advanced prostatic cancer. ANDA 75471, held by Meitheal. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 75471 (Leuprolide Acetate), held by Meitheal, was first approved by FDA on Oct 25, 2000, with 12 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 25, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leuprolide Acetate14MG/2.8ML (1MG/0.2ML) · solution;subcutaneous | Leuprolide Acetate | Rx |
| May 6, 2026 | Supplement 48Labeling · Standard review | Approved | None posted |
| Sep 23, 2025 | Supplement 45Labeling · Standard review | Approved | None posted |
| Sep 19, 2025 | Supplement 37Labeling · Standard review | Approved | None posted |
| Sep 19, 2025 | Supplement 38Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 33Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 35Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 36Labeling · Standard review | Approved | None posted |
| Jan 31, 2013 | Supplement 26Labeling · Standard review | Approved | None posted |
| Aug 9, 2012 | Supplement 24Labeling | Approved | None posted |
| Mar 28, 2011 | Supplement 16Labeling | Approved | None posted |
| May 27, 2009 | Supplement 7Labeling | Approved | None posted |
| Sep 20, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Oct 25, 2000 | 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
