Treats dysfunctions associated with hyperprolactinemia including amenorrhea with or…. ANDA 77226, held by Mylan. Bromocriptine Mesylate.
As of Nov 15, 2026, ANDA 77226 (Bromocriptine Mesylate), held by Mylan, was first approved by FDA on Apr 4, 2005, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets and capsules are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine 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. In cases where adenectomy is elected, a course of bromocriptine therapy may be used to reduce the tumor mass prior to surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 4, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromocriptine MesylateEQ 5MG BASE · capsule;oral | Bromocriptine Mesylate | Rx |
| Aug 21, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 13, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 15, 2006 | Supplement 1Labeling | Approved | None posted |
| Apr 4, 2005 | 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
