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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091619

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NDA 091619 describes DISULFIRAM, which is a drug marketed by Alvogen, Chartwell Molecules, Dash Pharms, Hikma, Sigmapharm Labs Llc, Strides Pharma Intl, Watson Labs, and Watson Labs Teva, and is included in eleven NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the disulfiram profile page.

Summary for 091619

Tradename:	DISULFIRAM
Applicant:	Sigmapharm Labs Llc
Ingredient:	disulfiram
Patents:	0

Pharmacology for NDA: 091619

Mechanism of Action	Acetyl Aldehyde Dehydrogenase Inhibitors

Medical Subject Heading (MeSH) Categories for 091619

Acetaldehyde Dehydrogenase Inhibitors
Alcohol Deterrents

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	Sigmapharm Laboratories, LLC	42794-028	42794-028-08	30 TABLET in 1 BOTTLE (42794-028-08)
DISULFIRAM	disulfiram	TABLET;ORAL	091619	ANDA	Sigmapharm Laboratories, LLC	42794-029	42794-029-08	30 TABLET in 1 BOTTLE (42794-029-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Mar 28, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Mar 28, 2011	TE:	AB	RLD:	No

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