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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 218109

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NDA 218109 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 218109

Tradename:	CABERGOLINE
Applicant:	Somerset Theraps Llc
Ingredient:	cabergoline
Patents:	0

Pharmacology for NDA: 218109

Suppliers and Packaging for NDA: 218109

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CABERGOLINE	cabergoline	TABLET;ORAL	218109	ANDA	Somerset Therapeutics, LLC	70069-824	70069-824-08	8 TABLET in 1 BOTTLE (70069-824-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Sep 9, 2024	TE:	AB	RLD:	No

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