FDA.reportPublic FDA data

Application 202993

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEDEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATECAPSULE;ORAL20MG;10MGNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextromethorphan hydrobromide and quinidine sulfateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATECamber Pharmaceuticals, Inc.7028dcb7-f436-4cf6-9beb-23c1d215c7982025-02-03Warnings, Adverse reactionsName fallback
brand name: Dextromethorphan hydrobromide and quinidine sulfate

Reported adverse events (FAERS/openFDA)#

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