FDA.reportPublic FDA data

Application 078767

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINTABLET; ORAL250MGNoNo
002LEVOFLOXACINLEVOFLOXACINTABLET; ORAL500MGNoNo
003LEVOFLOXACINLEVOFLOXACINTABLET; ORAL750MGNoNo

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 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9775LevofloxacinLevofloxacinWest-ward Pharmaceutical CorpANDACurrent
0143-9776LevofloxacinLevofloxacinWest-ward Pharmaceutical CorpANDACurrent
0143-9777LevofloxacinLevofloxacinWest-ward Pharmaceutical CorpANDACurrent
59115-095LevofloxacinLevofloxacinHikma PharmaceuticalANDACurrent
59115-096LevofloxacinLevofloxacinHikma PharmaceuticalANDACurrent
59115-097LevofloxacinLevofloxacinHikma PharmaceuticalANDACurrent