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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 086841

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NDA 086841 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 086841

Tradename:	DAPSONE
Applicant:	Everest Life Sci
Ingredient:	dapsone
Patents:	0

Pharmacology for NDA: 086841

Medical Subject Heading (MeSH) Categories for 086841

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 086841

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPSONE	dapsone	TABLET;ORAL	086841	ANDA	AvKARE	42291-008	42291-008-01	100 TABLET in 1 BOTTLE (42291-008-01)
DAPSONE	dapsone	TABLET;ORAL	086841	ANDA	Jacobus Pharmaceutical Company, Inc.	49938-102	49938-102-30	2 BLISTER PACK in 1 CARTON (49938-102-30) / 15 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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