FDA.reportPublic FDA data

Application 202525

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202525-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12015-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202525-001AT1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202525-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12015-03-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202525-001AT11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.bd0c0690-ba48-41c5-b76b-b1a53c36f4242026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERedpharm Drug51d45346-5506-d2c9-e063-6394a90ae6bb2026-05-15Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAvPAK371ca7b2-c62d-ef4b-3076-890b385bfff82026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMylan Institutional LLCc6fa4129-2f92-4179-ac5d-bb7b4a5387892026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be5b7a6f-9ee3-4453-807e-4761fffff60c2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a98b20d-c4a1-4184-8387-a4866d1d62bf2026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.18b77b31-baf3-416f-b3b7-a631c8e46d202026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepack6cd420c3-113e-4fc2-b59f-bfc7c485c14d2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MOXIFLOXACIN HYDROCHLORIDE
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
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac8a81b9-2fed-412a-8c83-db8dee1061f62025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERising Pharma Holdings, Inc.f34c08e6-fe74-4de3-9e36-a82c3c1c183b2025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions37466c79-8726-4fd6-9412-0bb83d523fe32025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
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
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.54377276-96bf-4140-9e90-55623ab6b0132025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.8f92f110-32d6-4d0c-a415-7a9a4cafb9b82025-04-19Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDESomerset Therapeutics, LLCf7c68d49-8c61-4bde-a880-4d78568e5aa02024-11-25Warnings, Adverse reactionsName fallback
brand name: Moxifloxacin Hydrochloride
generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions02c29e8e-8346-4e28-b7fc-2f4cb61ad37d2024-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MOXIFLOXACIN HYDROCHLORIDE
generic name: MOXIFLOXACIN HYDROCHLORIDE