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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
Applicant:Sanofi Aventis Us
Ingredient:enoxaparin sodium
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 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.