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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Accenture
Boehringer Ingelheim
Baxter
McKinsey
Teva
Healthtrust
Fuji

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200142

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NDA 200142 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Glenmark Generics, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in four NDAs. It is available from ten suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.

The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
Summary for 200142
Tradename:ACAMPROSATE CALCIUM
Applicant:Mylan Pharms Inc
Ingredient:acamprosate calcium
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 200142 ANDA Mylan Pharmaceuticals Inc. 0378-6333 N 0378-6333-80
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 200142 ANDA Mylan Institutional Inc. 51079-241 N 51079-241-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength333MG
Approval Date:Mar 11, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Harvard Business School
Julphar
AstraZeneca
Cantor Fitzgerald
Cipla
Cerilliant
Mallinckrodt

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