FDA.reportPublic FDA data

Application 203190

Type
ANDA
Sponsor
HI-TECH PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GATIFLOXACINGATIFLOXACINSOLUTION; OPHTHALMIC0.3%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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GATIFLOXACINGATIFLOXACINLeading Pharma, LLC826cf8c4-4be5-4614-bd42-47c1d0c9df582025-10-28Warnings, Adverse reactionsName fallback
brand name: GATIFLOXACIN
generic name: GATIFLOXACIN
GatifloxacinGATIFLOXACINSandoz Inc9e6fcd14-1fee-493f-811c-e18cbfbee65b2025-02-15Warnings, Adverse reactionsName fallback
brand name: Gatifloxacin
generic name: GATIFLOXACIN
ZYMAXIDGATIFLOXACINAllergan, Inc.1160b16c-929a-4e85-9c0b-1d8c96a7678b2016-09-08Warnings, Adverse reactionsName fallback
generic name: GATIFLOXACIN

Reported adverse events (FAERS/openFDA)#

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