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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218618

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NDA 218618 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the cabergoline profile page.

Summary for 218618

Tradename:	CABERGOLINE
Applicant:	Amneal
Ingredient:	cabergoline
Patents:	0

Pharmacology for NDA: 218618

Suppliers and Packaging for NDA: 218618

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CABERGOLINE	cabergoline	TABLET;ORAL	218618	ANDA	A-S Medication Solutions	50090-7642	50090-7642-0	8 TABLET in 1 BOTTLE (50090-7642-0)
CABERGOLINE	cabergoline	TABLET;ORAL	218618	ANDA	Amneal Pharmaceuticals NY LLC	69238-2693	69238-2693-1	8 TABLET in 1 BOTTLE (69238-2693-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Jun 26, 2024	TE:	AB	RLD:	No

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