FDA.reportPublic FDA data

Application 090950

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINASTINE HYDROCHLORIDEEPINASTINE HYDROCHLORIDESOLUTION; OPHTHALMIC0.05%NoNo

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
EPINASTINE HYDROCHLORIDEEPINASTINE HYDROCHLORIDESomerset Therapeutics, LLC0d4ee45c-e58f-4b7c-b389-898f5c27f54d2025-03-22Warnings, Adverse reactionsName fallback
brand name: EPINASTINE HYDROCHLORIDE
generic name: EPINASTINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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