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Last Updated: July 29, 2021

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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. Thirteen 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
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
Paragraph IV (Patent) Challenges for 020164
Tradename Dosage Ingredient NDA Submissiondate
LOVENOX (PRESERVATIVE FREE) INJECTABLE;SUBCUTANEOUS enoxaparin sodium 020164 2006-12-07
LOVENOX INJECTABLE;INTRAVENOUS, SUBCUTANEOUS enoxaparin sodium 020164 2006-12-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Mar 29, 1993TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Jan 30, 1998TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Mar 27, 1998TE:APRLD:Yes

Expired US Patents for NDA 020164

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
Medtronic
McKinsey
AstraZeneca
Colorcon

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