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US Army
Daiichi Sankyo
Queensland Health
Farmers Insurance

Generated: June 25, 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 nine 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. Nine suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
Summary for 200143
Applicant:Barr Labs Div Teva
Ingredient:acamprosate calcium
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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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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