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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 206505

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NDA 206505 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 206505

Tradename:	DAPSONE
Applicant:	Novitium Pharma
Ingredient:	dapsone
Patents:	0

Pharmacology for NDA: 206505

Medical Subject Heading (MeSH) Categories for 206505

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 206505

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	TABLET;ORAL	206505	ANDA	ANI Pharmaceuticals, Inc.	70954-135	70954-135-10	30 TABLET in 1 BOTTLE (70954-135-10)
DAPSONE	dapsone	TABLET;ORAL	206505	ANDA	ANI Pharmaceuticals, Inc.	70954-135	70954-135-20	100 TABLET in 1 BOTTLE (70954-135-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Dec 1, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 1, 2016	TE:	AB	RLD:	No

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