Last Updated: August 8, 2026

Details for New Drug Application (NDA): 213414

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NDA 213414 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Cosette Pharms Nc, Encube, Mylan, Sun Pharma Canada, Torrent, Tp Anda Holdings, Zydus Lifesciences, Actavis Llc, Alvogen, Everest Life Sci, Macleods Pharms Ltd, Novitium Pharma, Rising, Solis Pharms, and Taro, and is included in twenty-seven 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 213414

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

Pharmacology for NDA: 213414

Medical Subject Heading (MeSH) Categories for 213414

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 213414

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	213414	ANDA	Alembic Pharmaceuticals Limited	46708-551	46708-551-30	1 TUBE in 1 CARTON (46708-551-30) / 30 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	213414	ANDA	Alembic Pharmaceuticals Limited	46708-551	46708-551-60	1 TUBE in 1 CARTON (46708-551-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Jun 25, 2026	TE:	AB	RLD:	No

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