Cabergoline

Treats hyperprolactinemic disorders. ANDA 76310, held by Strides Pharma Intl. Cabergoline.

As of Nov 14, 2026, ANDA 76310 (Cabergoline), held by Strides Pharma Intl, was first approved by FDA on Dec 29, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2005
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 29, 2005	Original application	Approved	Letter

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 18Labeling · Standard review	Approved	None posted
Dec 13, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Oct 26, 2011	Supplement 5Labeling	Approved	None posted
Jun 4, 2008	Supplement 2Labeling	Approved	None posted
Jan 25, 2007	Supplement 1Labeling	Approved	None posted
Dec 29, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 76310
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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