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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076310

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NDA 076310 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, Somerset Theraps Llc, and Strides Pharma Intl, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the CABERGOLINE profile page.

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

Summary for 076310

Tradename:	CABERGOLINE
Applicant:	Strides Pharma Intl
Ingredient:	cabergoline
Patents:	0

Pharmacology for NDA: 076310

Suppliers and Packaging for NDA: 076310

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CABERGOLINE	cabergoline	TABLET;ORAL	076310	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-823	23155-823-73	8 TABLET in 1 BOTTLE (23155-823-73)
CABERGOLINE	cabergoline	TABLET;ORAL	076310	ANDA	A-S Medication Solutions	50090-6596	50090-6596-0	8 TABLET in 1 BOTTLE (50090-6596-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Dec 29, 2005	TE:	AB	RLD:	No

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