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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Fish and Richardson

Generated: December 18, 2017

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

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 10135-636-32 180 TABLET, DELAYED RELEASE in 1 BOTTLE (10135-636-32)
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 202229 ANDA American Health Packaging 60687-121 60687-121-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-121-25) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-121-95)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson

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