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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 215087

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NDA 215087 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 215087

Tradename:	DAPSONE
Applicant:	Padagis Israel
Ingredient:	dapsone
Patents:	0

Medical Subject Heading (MeSH) Categories for 215087

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Oct 31, 2023	TE:		RLD:	No

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