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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 218457

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NDA 218457 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-four NDAs. It is available from twenty-nine 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-two suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 218457

Tradename:	DAPSONE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	dapsone
Patents:	0

Pharmacology for NDA: 218457

Medical Subject Heading (MeSH) Categories for 218457

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 218457

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	218457	ANDA	Aurobindo Pharma Limited	59651-666	59651-666-60	1 TUBE in 1 CARTON (59651-666-60) / 60 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	218457	ANDA	Aurobindo Pharma Limited	59651-666	59651-666-90	1 TUBE in 1 CARTON (59651-666-90) / 90 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Apr 4, 2025	TE:	AB	RLD:	No

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