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Generated: December 16, 2018

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Details for New Drug Application (NDA): 088483

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NDA 088483 describes ANTABUSE, which is a drug marketed by Odyssey Pharms and Teva Womens and is included in three NDAs. It is available from two 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. Eight suppliers are listed for this compound. Additional details are available on the disulfiram profile page.
Summary for 088483
Applicant:Odyssey Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 088483
Medical Subject Heading (MeSH) Categories for 088483
Suppliers and Packaging for NDA: 088483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANTABUSE disulfiram TABLET;ORAL 088483 ANDA Teva Pharmaceuticals USA, Inc. 0093-5036 0093-5036-01 100 TABLET in 1 BOTTLE (0093-5036-01)
ANTABUSE disulfiram TABLET;ORAL 088483 ANDA Teva Women's Health, Inc. 51285-524 51285-524-02 100 TABLET in 1 BOTTLE (51285-524-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 8, 1983TE:ABRLD:No

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