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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 212701

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NDA 212701 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 212701

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

Pharmacology for NDA: 212701

Medical Subject Heading (MeSH) Categories for 212701

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 212701

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	212701	ANDA	Amneal Pharmaceuticals NY LLC	69238-1627	69238-1627-6	1 BOTTLE, PUMP in 1 CARTON (69238-1627-6) / 60 g in 1 BOTTLE, PUMP
DAPSONE	dapsone	GEL;TOPICAL	212701	ANDA	Amneal Pharmaceuticals NY LLC	69238-1627	69238-1627-9	1 BOTTLE, PUMP in 1 CARTON (69238-1627-9) / 90 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	7.5%
Approval Date:	May 31, 2023	TE:	AB	RLD:	No

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