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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 214722

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NDA 214722 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-seven 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 suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 214722

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

Pharmacology for NDA: 214722

Medical Subject Heading (MeSH) Categories for 214722

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 214722

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	214722	ANDA	Torrent Pharmaceuticals Limited	13668-605	13668-605-05	1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP
DAPSONE	dapsone	GEL;TOPICAL	214722	ANDA	Torrent Pharmaceuticals Limited	13668-605	13668-605-08	1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	7.5%
Approval Date:	Feb 10, 2022	TE:	AB	RLD:	No

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