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Generated: December 14, 2017

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 five suppliers. Additional details are available on the CABERGOLINE profile page.

The generic ingredient in CABERGOLINE is cabergoline. There are eleven 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 201503

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 201503

Ingredient-typeErgolines

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 60505-2597-2 8 TABLET in 1 BOTTLE (60505-2597-2)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Accenture
Johnson and Johnson
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Julphar
Healthtrust
Moodys
Teva
Farmers Insurance
Queensland Health
Cipla

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