ANDA 78899, held by Zydus Pharms USA Inc. Bromocriptine Mesylate.
As of Nov 15, 2026, ANDA 78899 (Bromocriptine Mesylate), held by Zydus Pharms USA Inc, was first approved by FDA on Jul 30, 2008, with 3 approved supplements and 0 published complete response letters.
Bromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older. Acromegaly in adults. Signs and symptoms of idiopathic Parkinson's disease or postencephalitic parkinsonism in adults. Limitations of Use Avoid use of bromocriptine mesylate capsule for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions ( 1.1, 5.4 ) 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bromocriptine MesylateEQ 5MG BASE · capsule;oral | Bromocriptine Mesylate | Rx |
| Apr 27, 2022 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 19, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 13, 2012 | Supplement 2Labeling | Approved | None posted |
| Jul 30, 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
