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Chinese Patent Office
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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201503

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NDA 201503 describes CABERGOLINE, which is a drug marketed by Actavis Labs Fl Inc, Apotex Corp, Impax Labs Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, and Par Pharm, and is included in six NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the cabergoline profile page.
Summary for 201503
Applicant:Apotex Corp
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Pharmacology for NDA: 201503
Suppliers and Packaging for NDA: 201503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CABERGOLINE cabergoline TABLET;ORAL 201503 ANDA Apotex Corp. 60505-2597 N 60505-2597-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 8, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Johnson and Johnson

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