Last Updated: June 26, 2026

Details for New Drug Application (NDA): 209430

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NDA 209430 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Aurobindo Pharma Ltd, Cosette, Encube, Mylan, Padagis Israel, Sun Pharma Canada, Torrent, Tp Anda Holdings, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Novitium Pharma, Rising, Solis Pharms, and Taro, and is included in twenty-five NDAs. It is available from twenty-eight suppliers. Additional details are available on the DAPSONE profile page.

The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 209430

Tradename:	DAPSONE
Applicant:	Taro
Ingredient:	dapsone
Patents:	0

Pharmacology for NDA: 209430

Medical Subject Heading (MeSH) Categories for 209430

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 209430

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	TABLET;ORAL	209430	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4197	51672-4197-6	30 TABLET in 1 BOTTLE (51672-4197-6)
DAPSONE	dapsone	TABLET;ORAL	209430	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4198	51672-4198-6	30 TABLET in 1 BOTTLE (51672-4198-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 1, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 1, 2019	TE:		RLD:	No

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