FDA.reportPublic FDA data

Application 089619

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAZOLAMIDE SODIUMACETAZOLAMIDE SODIUMInjectable; InjectionEQ 500MG BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDE SODIUMSagent Pharmaceuticals58093032-8480-4d0f-82be-92e643bdbea42026-01-09Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE SODIUM
AcetazolamideACETAZOLAMIDE SODIUMMylan Institutional LLC521838b0-a10d-495f-a014-f9ff25a6b6f32025-02-17Warnings, Adverse reactionsName fallback
generic name: ACETAZOLAMIDE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.