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Serving leading biopharmaceutical companies globally:

Chinese Patent Office

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091619

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NDA 091619 describes DISULFIRAM, which is a drug marketed by Chartwell Molecules, Mylan Pharms Inc, Par Pharm, Sigmapharm Labs Llc, Watson Labs, Watson Labs Teva, West-ward Pharms Int, and Alvogen Malta, and is included in eleven NDAs. 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 091619
Applicant:Sigmapharm Labs Llc
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091619
Medical Subject Heading (MeSH) Categories for 091619
Suppliers and Packaging for NDA: 091619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DISULFIRAM disulfiram TABLET;ORAL 091619 ANDA Bryant Ranch Prepack 63629-6854 63629-6854-1 30 TABLET in 1 BOTTLE (63629-6854-1)
DISULFIRAM disulfiram TABLET;ORAL 091619 ANDA Rising Pharmaceuticals, Inc. 64980-171 64980-171-01 100 TABLET in 1 BOTTLE (64980-171-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 28, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 28, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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