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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213907

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NDA 213907 describes DAPSONE, which is a drug marketed by Acrux Dds, Alembic, Amneal, Beloteca, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-three NDAs. It is available from twenty-four 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 213907

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

Pharmacology for NDA: 213907

Medical Subject Heading (MeSH) Categories for 213907

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 213907

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	213907	ANDA	Trupharma, LLC	52817-831	52817-831-60	1 TUBE in 1 CARTON (52817-831-60) / 60 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	213907	ANDA	Trupharma, LLC	52817-831	52817-831-90	1 TUBE in 1 CARTON (52817-831-90) / 90 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Jun 6, 2023	TE:	AB	RLD:	No

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