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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 207165

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NDA 207165 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 207165

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

Pharmacology for NDA: 207165

Medical Subject Heading (MeSH) Categories for 207165

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 207165

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	TABLET;ORAL	207165	ANDA	Rising Pharma Holdings, Inc.	64980-566	64980-566-01	100 TABLET in 1 BOTTLE (64980-566-01)
DAPSONE	dapsone	TABLET;ORAL	207165	ANDA	Rising Pharma Holdings, Inc.	64980-566	64980-566-03	30 TABLET in 1 BOTTLE (64980-566-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 8, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 20, 2023	TE:	AB	RLD:	No

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