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Federal Trade Commission
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AstraZeneca
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088482

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NDA 088482 describes ANTABUSE, which is a drug marketed by Odyssey Pharms and Teva Womens and is included in three NDAs. It is available from three suppliers. Additional details are available on the ANTABUSE profile page.

The generic ingredient in ANTABUSE is disulfiram. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the disulfiram profile page.
Summary for 088482
Tradename:ANTABUSE
Applicant:Odyssey Pharms
Ingredient:disulfiram
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 088482
Medical Subject Heading (MeSH) Categories for 088482
Suppliers and Packaging for NDA: 088482
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANTABUSE disulfiram TABLET;ORAL 088482 ANDA Teva Pharmaceuticals USA, Inc. 0093-5035 N 0093-5035-01
ANTABUSE disulfiram TABLET;ORAL 088482 ANDA Teva Women's Health, Inc. 51285-523 N 51285-523-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 8, 1983TE:ABRLD:No

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Chinese Patent Office
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