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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215718


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NDA 215718 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 215718
Tradename:DAPSONE
Applicant:Alembic
Ingredient:dapsone
Patents:0
Pharmacology for NDA: 215718
Medical Subject Heading (MeSH) Categories for 215718
Suppliers and Packaging for NDA: 215718
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone GEL;TOPICAL 215718 ANDA Alembic Pharmaceuticals Inc. 62332-663 62332-663-30 1 BOTTLE, PUMP in 1 CARTON (62332-663-30) / 30 g in 1 BOTTLE, PUMP
DAPSONE dapsone GEL;TOPICAL 215718 ANDA Alembic Pharmaceuticals Inc. 62332-663 62332-663-60 1 BOTTLE, PUMP in 1 CARTON (62332-663-60) / 60 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength7.5%
Approval Date:Oct 27, 2023TE:ABRLD:No

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