Last Updated: August 9, 2026

Details for New Drug Application (NDA): 220309

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NDA 220309 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 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 220309

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

Pharmacology for NDA: 220309

Suppliers and Packaging for NDA: 220309

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CABERGOLINE	cabergoline	TABLET;ORAL	220309	ANDA	Cranbury Pharmaceuticals, LLC	27808-315	27808-315-01	8 TABLET in 1 BOTTLE (27808-315-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Jun 15, 2026	TE:	AB	RLD:	No

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