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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 209890

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NDA 209890 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 209890

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

Pharmacology for NDA: 209890

Medical Subject Heading (MeSH) Categories for 209890

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 209890

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	209890	ANDA	Amneal Pharmaceuticals LLC	65162-339	65162-339-63	1 TUBE in 1 CARTON (65162-339-63) / 30 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	209890	ANDA	Amneal Pharmaceuticals LLC	65162-339	65162-339-85	1 TUBE in 1 CARTON (65162-339-85) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Oct 19, 2023	TE:	AB	RLD:	No

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