Treats advanced prostatic cancer. ANDA 74728, held by Sandoz. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 74728 (Leuprolide Acetate), held by Sandoz, was first approved by FDA on Aug 4, 1998, with 14 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 4, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leuprolide Acetate14MG/2.8ML (1MG/0.2ML) · solution;subcutaneous | Leuprolide Acetate | Rx |
| May 6, 2026 | Supplement 37Labeling · Standard review | Approved | None posted |
| Apr 30, 2026 | Supplement 36Labeling · Standard review | Approved | None posted |
| Sep 23, 2025 | Supplement 34Labeling · Standard review | Approved | None posted |
| Feb 1, 2021 | Supplement 22Labeling · Standard review | Approved | None posted |
| Feb 1, 2021 | Supplement 20Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 18Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 17, 2015 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 27, 2011 | Supplement 11Labeling | Approved | |
| Mar 28, 2011 | Supplement 10Labeling | Approved | None posted |
| Jul 6, 2008 | Supplement 7Labeling | Approved | None posted |
| Sep 13, 2006 | Supplement 6Labeling | Approved | None posted |
| Apr 3, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Nov 18, 1998 | Supplement 1Labeling | Approved | None posted |
| Aug 4, 1998 | 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
