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Serving hundreds of leading biopharmaceutical companies globally:

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Federal Trade Commission

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203887

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NDA 203887 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 203887
Applicant:Nostrum Labs Inc
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203887
Medical Subject Heading (MeSH) Categories for 203887
Suppliers and Packaging for NDA: 203887
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone TABLET;ORAL 203887 ANDA Nostrum Laboratories, Inc. 29033-036 N 29033-036-30
DAPSONE dapsone TABLET;ORAL 203887 ANDA Nostrum Laboratories, Inc. 29033-037 N 29033-037-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 6, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 6, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo

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