FDA.reportPublic FDA data

Application 090343

Type
ANDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 250MG/50ML (EQ 5MG/ML)NoYes
002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 500MG/100ML (EQ 5MG/ML)NoYes
003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 750MG/150ML (EQ 5MG/ML)NoYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07
A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07
A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090343-001AP
A090343-002AP
A090343-003AP

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 22:54:322026-06A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07a50c72e98297…
2026-08-01 22:54:322026-06A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07a50c72e98297…
2026-08-01 22:54:322026-06A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090343-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A090343-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A090343-003AP1a50c72e98297…

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINSagent Pharmaceuticals699fbdb8-a6fd-476a-9b80-08197d8695342026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090343
application number: ANDA090343
ndc (product): 25021-132
LevofloxacinLEVOFLOXACINHospira, Inc5a1534af-aa1c-4f1d-ba9f-9415b14e1af22025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090343
application number: ANDA090343
LevofloxacinLEVOFLOXACINWG Critical Care, LLC9020cdeb-65fe-458f-bbbd-69265a49906e2024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090343
application number: ANDA090343
ndc (product): 44567-437
ndc (product): 44567-435
ndc (product): 44567-436

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-132LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-825LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
25021-825LevofloxacinLevofloxacinSagent PharmaceuticalsANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-435LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-436LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent
44567-437LevofloxacinLevofloxacinWG Critical Care, LLCANDACurrent