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Deloitte
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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086841

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NDA 086841 describes DAPSONE, which is a drug marketed by Taro, Actavis Llc, Alvogen, Jacobus, Nostrum Labs Inc, Novitium Pharma, and Virtus Pharms, and is included in eight NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 086841
Tradename:DAPSONE
Applicant:Jacobus
Ingredient:dapsone
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 086841
Ingredient-typeSulfones
Medical Subject Heading (MeSH) Categories for 086841
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 Seton Pharmaceuticals 13925-504 N 13925-504-01
DAPSONE dapsone TABLET;ORAL 086841 ANDA Seton Pharmaceuticals 13925-504 N 13925-504-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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