Bromocriptine Mesylate

Treats dysfunctions associated with hyperprolactinemia including amenorrhea with or…. ANDA 74631, held by Sandoz. Bromocriptine Mesylate.

As of Nov 15, 2026, ANDA 74631 (Bromocriptine Mesylate), held by Sandoz, was first approved by FDA on Jan 13, 1998, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 13, 1998
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets, USP are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate tablets, USP 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 13, 1998	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bromocriptine MesylateEQ 2.5MG BASE · tablet;oral	Bromocriptine Mesylate	Rx

All 9 submissions, including labeling and manufacturing supplements


Nov 8, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Jan 7, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Jan 28, 2002	Supplement 5Manufacturing	Approved	None posted
Jan 28, 2002	Supplement 4Labeling	Approved	None posted
Jan 28, 2002	Supplement 3Manufacturing	Approved	None posted
Jan 28, 2002	Supplement 2Manufacturing	Approved	None posted
Jan 28, 2002	Supplement 1Manufacturing	Approved	None posted
Jan 13, 1998	Original application	Approved	None posted

Identifiers

Application: ANDA 74631
Drugs@FDA: Overview at FDA
Company: Sandoz

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