FDA.reportPublic FDA data

Application 022138

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOVENOXENOXAPARIN SODIUMINJECTABLE; INJECTION100MG/MLNoNo

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enoxaparin SodiumENOXAPARIN SODIUMCardinal Health 107, LLC45a66675-b159-42b8-9f18-ff80f28e15032026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
LovenoxENOXAPARIN SODIUMSanofi-Aventis U.S. LLC5017a927-2a24-4f27-89f9-27c805bf7d592026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lovenox
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMCardinal Health 107, LLC5e7568a6-cf8a-4de2-86ba-b94c8ab4c8062026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
LovenoxENOXAPARIN SODIUMCardinal Health 107, LLC3d263380-4f44-4fd8-aa2a-e69702ab258f2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lovenox
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLCc3be543e-8aff-4311-bf77-e7a5a814ca6f2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
enoxaparin sodiumENOXAPARIN SODIUMBE Pharmaceuticals Inc.b7197534-1daa-42de-8b83-a727da1195bf2026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
LovenoxENOXAPARIN SODIUMSanofi-Aventis U.S. LLCde6fb917-a94a-41ea-9d7d-937d4080ffcd2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lovenox
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLC21b095d1-5ade-43e9-9114-30fbfb2331c92026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLC066f27ec-352c-4051-ba29-248e292690db2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
ENOXAPARIN SODIUMENOXAPARIN SODIUMGland Pharma Limited65025e0d-eb54-4c4e-bd14-f294ce0389022026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
enoxaparin sodiumENOXAPARIN SODIUMHebei Changshan Biochemical Pharmaceutical Co., Ltd.7fa78f8d-92d9-434a-8e26-b886ab0ae77f2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.b6fb85ab-1fe5-4dd3-a97f-adbed0674f672026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.adbba7bb-fa72-4cec-aa69-13965591a45d2025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMBluePoint Laboratoriesd978e06e-b758-460b-81d3-69f7a5b89b002025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMBluePoint Laboratoriesa2a8615b-a27e-4ab2-ae4c-592bbf4643c02025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMZydus Pharmaceuticals USA Inc.d8afb29f-cbed-43bc-809f-09b30fca28f52024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMNorthStar Rx LLC32f8d292-0dda-4931-81ea-ba47e23edf612024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.7d38c307-767f-4c38-ac0e-b8bb627826022024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMNorthStar RxLLC014c6710-f2c4-fd1e-e063-6394a90ae5252024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM
Enoxaparin SodiumENOXAPARIN SODIUMSandoz Inc38f60bd8-b518-4098-a808-b8f5a3ae6a3a2024-06-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ENOXAPARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44174ORIG2013-11-07
42427ORIG2009-03-24
38297ORIG2007-05-29
29308ORIG2007-05-29