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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091681

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NDA 091681 describes DISULFIRAM , which is a drug marketed by Alvogen Malta and is included in one NDA. It is available from seven suppliers. Additional details are available on the DISULFIRAM profile page.

The generic ingredient in DISULFIRAM 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 091681
Tradename:DISULFIRAM
Applicant:Alvogen Malta
Ingredient:disulfiram
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091681
Medical Subject Heading (MeSH) Categories for 091681
Suppliers and Packaging for NDA: 091681
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DISULFIRAM disulfiram TABLET;ORAL 091681 ANDA Alvogen Inc. 47781-607 47781-607-01 100 TABLET in 1 BOTTLE (47781-607-01)
DISULFIRAM disulfiram TABLET;ORAL 091681 ANDA Alvogen Inc. 47781-607 47781-607-30 30 TABLET in 1 BOTTLE, PLASTIC (47781-607-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 8, 2013TE:ABRLD:No

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Baxter
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