Cabergoline

ANDA 78035, held by Actavis Labs Fl Inc. Cabergoline.

As of Nov 14, 2026, ANDA 78035 (Cabergoline), held by Actavis Labs Fl Inc, was first approved by FDA on Apr 21, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 21, 2008
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 21, 2008	Original application	Approved	Review

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Sep 25, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Apr 16, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Dec 13, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Apr 21, 2008	Original application	Approved	Review

Identifiers

Application: ANDA 78035
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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