Application 022138

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOVENOX	ENOXAPARIN SODIUM	INJECTABLE; INJECTION	100MG/ML	No	No

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	adfc2b23-00a5-4f05-a08b-83087e1e4843	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Italfarmaco SpA	b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9	2022-11-05		Name fallback generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Amphastar Pharmaceuticals, Inc.	3e6bf2b3-9339-4104-bda3-ad86a1949703	2022-09-01	Boxed warning, Warnings, Adverse reactions	Name 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
Document	Submission type	Date
44174	ORIG	2013-11-07
42427	ORIG	2009-03-24
38297	ORIG	2007-05-29
29308	ORIG	2007-05-29