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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 214722


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NDA 214722 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Beloteca, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-one NDAs. It is available from twenty 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-three suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 214722
Tradename:DAPSONE
Applicant:Torrent
Ingredient:dapsone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214722
Medical Subject Heading (MeSH) Categories for 214722
Suppliers and Packaging for NDA: 214722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone GEL;TOPICAL 214722 ANDA Torrent Pharmaceuticals Limited 13668-605 13668-605-05 1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP
DAPSONE dapsone GEL;TOPICAL 214722 ANDA Torrent Pharmaceuticals Limited 13668-605 13668-605-08 1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength7.5%
Approval Date:Feb 10, 2022TE:ABRLD:No

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