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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 209430

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NDA 209430 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 eleven 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. Fourteen suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 209430
Formulation / Manufacturing:see details
Pharmacology for NDA: 209430
Medical Subject Heading (MeSH) Categories for 209430
Suppliers and Packaging for NDA: 209430
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPSONE dapsone TABLET;ORAL 209430 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4197 51672-4197-2 2 BLISTER PACK in 1 CARTON (51672-4197-2) > 15 TABLET in 1 BLISTER PACK
DAPSONE dapsone TABLET;ORAL 209430 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4197 51672-4197-6 30 TABLET in 1 BOTTLE (51672-4197-6)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Mar 1, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Mar 1, 2019TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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