ANDA 75100, held by Lek Pharm. Bromocriptine Mesylate.
As of Nov 15, 2026, ANDA 75100 (Bromocriptine Mesylate), held by Lek Pharm, was first approved by FDA on Dec 10, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromocriptine MesylateEQ 5MG BASE ยท capsule;oral | Bromocriptine Mesylate | 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
