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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 020164

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NDA 020164 describes LOVENOX (PRESERVATIVE FREE), which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. Additional details are available on the LOVENOX (PRESERVATIVE FREE) profile page.

The generic ingredient in LOVENOX (PRESERVATIVE FREE) is enoxaparin sodium. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.

Summary for 020164

Tradename:	LOVENOX (PRESERVATIVE FREE)
Applicant:	Sanofi Aventis Us
Ingredient:	enoxaparin sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020164

Medical Subject Heading (MeSH) Categories for 020164

Anticoagulants
Fibrinolytic Agents

Suppliers and Packaging for NDA: 020164

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164	NDA	Sanofi-Aventis U.S. LLC	0075-0620	0075-0620-40	10 CELLO PACK in 1 CARTON (0075-0620-40) / 1 SYRINGE in 1 CELLO PACK (0075-0620-01) / .4 mL in 1 SYRINGE
LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164	NDA	Sanofi-Aventis U.S. LLC	0075-0621	0075-0621-60	10 CELLO PACK in 1 CARTON (0075-0621-60) / 1 SYRINGE in 1 CELLO PACK (0075-0621-01) / .6 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	30MG/0.3ML (100MG/ML)
Approval Date:	Mar 29, 1993	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	40MG/0.4ML (100MG/ML)
Approval Date:	Jan 30, 1998	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	60MG/0.6ML (100MG/ML)
Approval Date:	Mar 27, 1998	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020164

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	⤷ Try a Trial	⤷ Try a Trial
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-001	Mar 29, 1993	⤷ Try a Trial	⤷ Try a Trial
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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