Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203887

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NDA 203887 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 203887

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

Pharmacology for NDA: 203887

Medical Subject Heading (MeSH) Categories for 203887

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 203887

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	TABLET;ORAL	203887	ANDA	Solis Pharmaceuticals Inc.	85185-104	85185-104-01	30 TABLET in 1 BOTTLE (85185-104-01)
DAPSONE	dapsone	TABLET;ORAL	203887	ANDA	Solis Pharmaceuticals Inc.	85185-104	85185-104-02	100 TABLET in 1 BOTTLE (85185-104-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 6, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 6, 2016	TE:	AB	RLD:	No

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