ANDA 76094, held by Ivax Sub Teva Pharms. Pergolide Mesylate.
As of Nov 15, 2026, ANDA 76094 (Pergolide Mesylate), held by Ivax Sub Teva Pharms, was first approved by FDA on Sep 4, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 4, 2003 | Original application | Approved | None posted |
| Pergolide MesylateEQ 0.05MG BASE · tablet;oral | Pergolide Mesylate | Discontinued |
| Pergolide MesylateEQ 0.25MG BASE · tablet;oral | Pergolide Mesylate | Discontinued |
| Pergolide MesylateEQ 1MG BASE · tablet;oral | Pergolide 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
