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Last Updated: March 28, 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, Mylan, and Strides Pharma, and is included in seven NDAs. It is available from five 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. Six 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
Formulation / Manufacturing:see details
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:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 7, 2007TE:ABRLD:No

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