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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210178

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NDA 210178 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Trupharma, 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 210178

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

Pharmacology for NDA: 210178

Medical Subject Heading (MeSH) Categories for 210178

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 210178

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	210178	ANDA	Cosette Pharmaceuticals, Inc.	0713-0886	0713-0886-18	1 TUBE in 1 CARTON (0713-0886-18) / 90 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	210178	ANDA	Cosette Pharmaceuticals, Inc.	0713-0886	0713-0886-60	1 TUBE in 1 CARTON (0713-0886-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Mar 31, 2022	TE:	AB	RLD:	No

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