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Serving leading biopharmaceutical companies globally:

Queensland Health
Teva
Farmers Insurance
UBS
Mallinckrodt
Boehringer Ingelheim
US Army
AstraZeneca
Argus Health
Moodys

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200143

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NDA 200143 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 200143
Tradename:ACAMPROSATE CALCIUM
Applicant:Barr Labs Div Teva
Ingredient:acamprosate calcium
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200143
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 200143 ANDA Teva Pharmaceuticals USA, Inc. 0093-5352 N 0093-5352-86
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 200143 ANDA AvKARE, Inc. 42291-104 N 42291-104-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength333MG
Approval Date:Nov 18, 2013TE:ABRLD:No

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Federal Trade Commission
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Colorcon
Julphar
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Cerilliant
QuintilesIMS

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