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 1 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAmerican Health Packaging1ed191f5-7df5-488c-bb72-91ac0b618d9a2026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.bd0c0690-ba48-41c5-b76b-b1a53c36f4242026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERedpharm Drug51d45346-5506-d2c9-e063-6394a90ae6bb2026-05-15Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAvPAK371ca7b2-c62d-ef4b-3076-890b385bfff82026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMylan Institutional LLCc6fa4129-2f92-4179-ac5d-bb7b4a5387892026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be5b7a6f-9ee3-4453-807e-4761fffff60c2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a98b20d-c4a1-4184-8387-a4866d1d62bf2026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.18b77b31-baf3-416f-b3b7-a631c8e46d202026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepack6cd420c3-113e-4fc2-b59f-bfc7c485c14d2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
VIGAMOXMOXIFLOXACIN HYDROCHLORIDEHarrow Eye, LLC12053b08-7e66-c6f3-e063-6394a90a9cd92026-01-22Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMajor Pharmaceuticals815d71cf-02de-4190-9bd1-3fdc67ef0f062025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac8a81b9-2fed-412a-8c83-db8dee1061f62025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERising Pharma Holdings, Inc.f34c08e6-fe74-4de3-9e36-a82c3c1c183b2025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions37466c79-8726-4fd6-9412-0bb83d523fe32025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MoxifloxacinMOXIFLOXACIN HYDROCHLORIDESolaris Pharma Corporation45ce14e5-98b8-296b-e063-6294a90a769b2025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEAurobindo Pharma Limitedd6789c17-4a2f-4519-9060-e3b0dba422f02025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.54377276-96bf-4140-9e90-55623ab6b0132025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.8f92f110-32d6-4d0c-a415-7a9a4cafb9b82025-04-19Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDESomerset Therapeutics, LLCf7c68d49-8c61-4bde-a880-4d78568e5aa02024-11-25Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions02c29e8e-8346-4e28-b7fc-2f4cb61ad37d2024-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MOXIFLOXACIN HYDROCHLORIDE

Documents#

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