FDA.reportPublic FDA data

Application 021334

Type
NDA
Sponsor
BAYER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVELOXMOXIFLOXACIN HYDROCHLORIDETablet; Oral400MGNoNo

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCa4e28b09-714b-46e7-b4e6-0163cad78fc52024-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutionsc71e5987-edd7-4c38-b646-3e48a6e51bf42023-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEUpsher-Smith Laboratories, LLC5a5d72e2-aa39-4ead-af72-d3cabe72a5b72023-05-30Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Ophthalmic SolutionMOXIFLOXACIN HYDROCHLORIDESandoz Incfc88791b-24da-48a4-85f5-93a8af3d0b512020-06-15Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21603ORIG2004-05-27
5065ORIG2004-05-27
15208ORIG2003-05-07