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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 213907

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NDA 213907 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 213907

Tradename:	DAPSONE
Applicant:	Tp Anda Holdings
Ingredient:	dapsone
Patents:	0

Pharmacology for NDA: 213907

Medical Subject Heading (MeSH) Categories for 213907

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 213907

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	213907	ANDA	Trupharma, LLC	52817-831	52817-831-60	1 TUBE in 1 CARTON (52817-831-60) / 60 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	213907	ANDA	Trupharma, LLC	52817-831	52817-831-90	1 TUBE in 1 CARTON (52817-831-90) / 90 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Jun 6, 2023	TE:	AB	RLD:	No

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