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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202229

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NDA 202229 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 202229
Applicant:Glenmark Generics
Ingredient:acamprosate calcium
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202229
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 202229 ANDA Marlex Pharmaceuticals Inc 10135-636 N 10135-636-32
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 202229 ANDA American Health Packaging 60687-121 N 60687-121-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength333MG
Approval Date:Jul 16, 2013TE:ABRLD:No

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Harvard Business School
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