Treats dysfunctions associated with hyperprolactinemia including amenorrhea with or…. ANDA 77646, held by Padagis US. Bromocriptine Mesylate.
As of Nov 15, 2026, ANDA 77646 (Bromocriptine Mesylate), held by Padagis US, was first approved by FDA on Oct 1, 2008, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate tablets treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromocriptine MesylateEQ 2.5MG BASE · tablet;oral | Bromocriptine Mesylate | Rx |
| Apr 27, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 21, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 1, 2008 | 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
