ANDA 76962, held by Aurobindo Pharma USA. Bromocriptine Mesylate.
As of Nov 15, 2026, ANDA 76962 (Bromocriptine Mesylate), held by Aurobindo Pharma USA, was first approved by FDA on Sep 24, 2004, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromocriptine MesylateEQ 2.5MG BASE · tablet;oral | Bromocriptine Mesylate | Discontinued |
| Aug 21, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 13, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 15, 2006 | Supplement 1Labeling | Approved | None posted |
| Sep 24, 2004 | Original application | Approved |
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
