Treats advanced prostatic cancer. ANDA 217437, held by Ph Health. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 217437 (Leuprolide Acetate), held by Ph Health, was first approved by FDA on Jun 9, 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 |
|---|---|---|---|
| Jun 9, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leuprolide Acetate14MG/2.8ML (1MG/0.2ML) · solution;subcutaneous | Leuprolide Acetate | Discontinued |
| May 6, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 9, 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
