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Serving 500+ biopharmaceutical companies globally:

US Army
Fish and Richardson
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US Department of Justice
Chubb
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Healthtrust
Covington
UBS
Cipla

Generated: August 21, 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 Apotex Corp, Par Pharm, Actavis Labs Fl Inc, Impax Labs Inc, Mylan Pharms Inc, and Ivax Sub Teva Pharms, 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 NDA: 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 500+ biopharmaceutical companies globally:

Colorcon
Deloitte
McKesson
Boehringer Ingelheim
Express Scripts
Chubb
Citi
Moodys
Covington
Argus Health

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