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Last Updated: November 30, 2021

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, Taro Pharms, Actavis Llc, Alvogen, Jacobus, Nostrum Labs Inc, Novitium Pharma, Rising, and Virtus Pharms, and is included in eleven NDAs. It is available from nine 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. Twelve suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 203887
Applicant:Nostrum Labs Inc
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 29033-036-30 30 TABLET in 1 BOTTLE (29033-036-30)
DAPSONE dapsone TABLET;ORAL 203887 ANDA Nostrum Laboratories, Inc. 29033-037 29033-037-30 30 TABLET in 1 BOTTLE (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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