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Last Updated: November 2, 2024

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, Apotex Corp, Impax Labs Inc, Ingenus Pharms Llc, Ivax Sub Teva Pharms, Norvium Bioscience, Skg Pharma, Strides Pharma, and Welding, and is included in nine NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the cabergoline profile page.
Summary for 218618
Tradename:CABERGOLINE
Applicant:Skg Pharma
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 Amneal Pharmaceuticals NY LLC 69238-2693 69238-2693-1 8 TABLET in 1 BOTTLE (69238-2693-1)
CABERGOLINE cabergoline TABLET;ORAL 218618 ANDA SKG Pharma Inc. 83085-003 83085-003-08 8 TABLET in 1 BOTTLE (83085-003-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jun 26, 2024TE:ABRLD:No

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