Last Updated: September 24, 2026

Details for New Drug Application (NDA): 201503

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NDA 201503 describes CABERGOLINE, which is a drug marketed by Actavis Labs Fl Inc, Amneal, Apotex Corp, Impax Labs Inc, Ingenus Pharms Llc, Ivax Sub Teva Pharms, Pharmobedient, Renata, Somerset Theraps Llc, and Strides Pharma Intl, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the CABERGOLINE profile page.

The generic ingredient in CABERGOLINE is cabergoline. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the cabergoline profile page.

Summary for 201503

Tradename:	CABERGOLINE
Applicant:	Apotex Corp
Ingredient:	cabergoline
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Mar 8, 2013	TE:		RLD:	No

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