FDA.reportPublic FDA data

Application 220326

Type
ANDA
Sponsor
APPCO PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002VILOXAZINE HYDROCHLORIDEVILOXAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE200MGNoNo
003VILOXAZINE HYDROCHLORIDEVILOXAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE150MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QELBREEVILOXAZINE HYDROCHLORIDESupernus Pharmaceuticals, Incaedf408d-0f84-418d-9416-7c39ddb0d29a2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VILOXAZINE HYDROCHLORIDE