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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 214019


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NDA 214019 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 214019
Tradename:DAPSONE
Applicant:Zydus Lifesciences
Ingredient:dapsone
Patents:0
Pharmacology for NDA: 214019
Medical Subject Heading (MeSH) Categories for 214019
Suppliers and Packaging for NDA: 214019
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone GEL;TOPICAL 214019 ANDA Zydus Lifesciences Limited 70771-1538 70771-1538-2 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP
DAPSONE dapsone GEL;TOPICAL 214019 ANDA Zydus Lifesciences Limited 70771-1538 70771-1538-3 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength7.5%
Approval Date:May 8, 2024TE:ABRLD:No

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