FDA.reportPublic FDA data

Application 021199

Type
NDA
Sponsor
SANTEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUIXINLEVOFLOXACINSOLUTION/DROPS;OPHTHALMIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021199-001QUIXINLEVOFLOXACIN0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2000-08-18

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021199-001QUIXIN0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2000-08-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021199-001QUIXIN0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2000-08-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021199-001QUIXIN0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2000-08-18a50c72e98297…

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 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINRedpharm Drug5a65b2bc-9edc-f193-e063-6394a90a01042026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINCoupler LLC59f387a4-4dfa-ba71-e063-6294a90a340c2026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINMajor Pharmaceuticalsac4001ca-882f-4d9b-a570-c1b9d7fd68302026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINBryant Ranch Prepackb9dc8bf3-97d9-4d1c-9a68-3ae553acdada2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINSagent Pharmaceuticals699fbdb8-a6fd-476a-9b80-08197d8695342026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINHAWAII REPACK, INC.857f256c-88ac-4f73-9815-c2724edf2f1e2026-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.2a4e97e0-0709-411b-92e8-6f7d669412e42026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.710c0c10-89a5-4954-8f74-acc187c5cf0f2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINChartwell RX, LLC5c6c117c-9d91-48f4-9aaa-ee70b99218c22026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.f14cf651-a213-4a4f-adb9-f628562af27c2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINCardinal Health 107, LLC070375be-3b67-4299-ae8f-4a7b157ac16f2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.bcad1dad-53aa-43dd-90f3-cc17cc9598d52026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.2a8676a9-247f-4fdb-b644-e9785d98771f2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LEVOFLOXACINLEVOFLOXACINDIRECT RX4f40d5fa-ebcc-516c-e054-00144ff8d46c2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.a5ae33ad-4703-4cb2-8618-6439c906be992026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOFLOXACIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
14624SUPPL2014-12-10
4617SUPPL2014-12-04
36328SUPPL2005-04-12
27044SUPPL2005-04-12
14623SUPPL2005-04-12
4616SUPPL2005-04-12
42015ORIG2004-03-24
36327SUPPL2002-06-04
27043SUPPL2002-06-04
36326SUPPL2002-04-18
4615SUPPL2002-04-18
36325ORIG2000-08-18
4614ORIG2000-08-18