FDA.reportPublic FDA data

Application 078577

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACININJECTABLE;INJECTIONEQ 500MG/20ML (EQ 25MG/ML)NoNo
002LEVOFLOXACINLEVOFLOXACININJECTABLE;INJECTIONEQ 750MG/30ML (EQ 25MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078577-001LEVOFLOXACINLEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTION2015-08-12
A078577-002LEVOFLOXACINLEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTION2015-08-12

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 22:54:322026-06A078577-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTION2015-08-12a50c72e98297…
2026-08-01 22:54:322026-06A078577-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTION2015-08-12a50c72e98297…

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINSagent Pharmaceuticals699fbdb8-a6fd-476a-9b80-08197d8695342026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINHAWAII REPACK, INC.857f256c-88ac-4f73-9815-c2724edf2f1e2026-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.2a4e97e0-0709-411b-92e8-6f7d669412e42026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.710c0c10-89a5-4954-8f74-acc187c5cf0f2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINChartwell RX, LLC5c6c117c-9d91-48f4-9aaa-ee70b99218c22026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.f14cf651-a213-4a4f-adb9-f628562af27c2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINCardinal Health 107, LLC070375be-3b67-4299-ae8f-4a7b157ac16f2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.bcad1dad-53aa-43dd-90f3-cc17cc9598d52026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.2a8676a9-247f-4fdb-b644-e9785d98771f2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LEVOFLOXACINLEVOFLOXACINDIRECT RX4f40d5fa-ebcc-516c-e054-00144ff8d46c2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOFLOXACIN
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.a5ae33ad-4703-4cb2-8618-6439c906be992026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levofloxacin
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levofloxacin
generic name: LEVOFLOXACIN
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.b8ac5047-5203-42c4-886b-dd0b08a1786f2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.16d51c1c-4144-4be7-9356-98fcee621ecd2026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf2f090c2-3ee1-7689-e053-2995a90abe382026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf780bb91-483a-d1a6-e053-6294a90ab74b2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levofloxacin
generic name: LEVOFLOXACIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9167ORIG2015-08-13