Last Updated: November 8, 2026

Details for New Drug Application (NDA): 218335

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NDA 218335 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Cosette Pharms Nc, Encube, Mylan, Sun Pharma Canada, Torrent, Tp Anda Holdings, Zydus Lifesciences, Actavis Llc, Alvogen, Everest Life Sci, Macleods Pharms, Novitium Pharma, Rising, Solis Pharms, and Taro, and is included in twenty-seven 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 is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 218335

Tradename:	DAPSONE
Applicant:	Macleods Pharms
Ingredient:	dapsone
Patents:	0

Pharmacology for NDA: 218335

Medical Subject Heading (MeSH) Categories for 218335

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 218335

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	TABLET;ORAL	218335	ANDA	Macleods Pharmaceuticals Limited	33342-534	33342-534-07	30 TABLET in 1 BOTTLE (33342-534-07)
DAPSONE	dapsone	TABLET;ORAL	218335	ANDA	Macleods Pharmaceuticals Limited	33342-534	33342-534-11	100 TABLET in 1 BOTTLE (33342-534-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 8, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 8, 2026	TE:	AB	RLD:	No

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