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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 077750

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NDA 077750 describes CABERGOLINE, which is a drug marketed by Actavis Labs Fl Inc, Apotex Corp, Impax Labs Inc, Ingenus Pharms Llc, Ivax Sub Teva Pharms, Norvium Bioscience, Skg Pharma, Somerset Theraps Llc, and Strides Pharma, 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 077750

Tradename:	CABERGOLINE
Applicant:	Ivax Sub Teva Pharms
Ingredient:	cabergoline
Patents:	0

Pharmacology for NDA: 077750

Suppliers and Packaging for NDA: 077750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CABERGOLINE	cabergoline	TABLET;ORAL	077750	ANDA	Teva Pharmaceuticals USA, Inc.	0093-5420	0093-5420-88	1 BOTTLE in 1 CARTON (0093-5420-88) / 8 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Mar 7, 2007	TE:	AB	RLD:	No

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