Cabergoline

Treats hyperprolactinemic disorders. ANDA 77750, held by Ivax Sub Teva Pharms. Cabergoline.

As of Nov 14, 2026, ANDA 77750 (Cabergoline), held by Ivax Sub Teva Pharms, was first approved by FDA on Mar 7, 2007, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 7, 2007
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 7, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cabergoline0.5MG · tablet;oral	Cabergoline	Rx

All 7 submissions, including labeling and manufacturing supplements


Jun 28, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Dec 13, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Oct 26, 2011	Supplement 5Labeling	Approved	None posted
Oct 26, 2011	Supplement 6Labeling	Approved	None posted
Mar 12, 2008	Supplement 2Labeling	Approved	None posted
Oct 1, 2007	Supplement 1Labeling	Approved	None posted
Mar 7, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77750
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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