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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 212383

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NDA 212383 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 212383

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

Pharmacology for NDA: 212383

Medical Subject Heading (MeSH) Categories for 212383

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 212383

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	GEL;TOPICAL	212383	ANDA	Encube Ethicals Private Limited	21922-018	21922-018-07	1 TUBE in 1 CARTON (21922-018-07) / 60 g in 1 TUBE
DAPSONE	dapsone	GEL;TOPICAL	212383	ANDA	Encube Ethicals Private Limited	21922-018	21922-018-08	1 TUBE in 1 CARTON (21922-018-08) / 90 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Oct 13, 2023	TE:	AB	RLD:	No

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