Treats advanced prostatic cancer. ANDA 78885, held by Sun Pharm. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 78885 (Leuprolide Acetate), held by Sun Pharm, was first approved by FDA on Mar 9, 2009, with 10 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 |
|---|---|---|---|
| Mar 9, 2009 | 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 40Labeling · Standard review | Approved | None posted |
| Sep 23, 2025 | Supplement 39Labeling · Standard review | Approved | None posted |
| Sep 19, 2025 | Supplement 32Labeling · Standard review | Approved | None posted |
| Nov 20, 2020 | Supplement 25Labeling · Standard review | Approved | None posted |
| Nov 20, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 15Labeling · Standard review | Approved | None posted |
| May 19, 2017 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 8, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 26, 2011 | Supplement 5Labeling | Approved | None posted |
| Mar 28, 2011 | Supplement 3Labeling | Approved | None posted |
| Mar 9, 2009 | 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
