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Daiichi Sankyo
Cantor Fitzgerald
Federal Trade Commission
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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205429

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NDA 205429 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 fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 205429
Tradename:DAPSONE
Applicant:Alvogen
Ingredient:dapsone
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205429
Ingredient-typeSulfones
Medical Subject Heading (MeSH) Categories for 205429
Suppliers and Packaging for NDA: 205429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone TABLET;ORAL 205429 ANDA Alvogen Inc. 47781-333 N 47781-333-31
DAPSONE dapsone TABLET;ORAL 205429 ANDA Alvogen Inc. 47781-334 N 47781-334-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 7, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 7, 2016TE:ABRLD:No

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Medtronic
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