ANDA 75721, held by Genzyme. Leuprolide Acetate.
As of Nov 15, 2026, ANDA 75721 (Leuprolide Acetate), held by Genzyme, was first approved by FDA on Nov 29, 2001, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leuprolide Acetate14MG/2.8ML (1MG/0.2ML) ยท solution;subcutaneous | Leuprolide Acetate | Discontinued |
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
