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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204380

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NDA 204380 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 204380

Tradename:	DAPSONE
Applicant:	Actavis Llc
Ingredient:	dapsone
Patents:	0

Medical Subject Heading (MeSH) Categories for 204380

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 23, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 23, 2017	TE:	AB	RLD:	No

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