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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 086842


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NDA 086842 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 086842
Tradename:DAPSONE
Applicant:Everest Life Sci
Ingredient:dapsone
Patents:0
Pharmacology for NDA: 086842
Medical Subject Heading (MeSH) Categories for 086842
Suppliers and Packaging for NDA: 086842
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone TABLET;ORAL 086842 ANDA Jacobus Pharmaceutical Company, Inc. 49938-101 49938-101-28 2 BLISTER PACK in 1 CARTON (49938-101-28) / 14 TABLET in 1 BLISTER PACK
DAPSONE dapsone TABLET;ORAL 086842 ANDA Jacobus Pharmaceutical Company, Inc. 49938-101 49938-101-30 2 BLISTER PACK in 1 CARTON (49938-101-30) / 15 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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