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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 five suppliers. Additional details are available on the LOVENOX (PRESERVATIVE FREE) profile page.

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

Summary for NDA: 020164

Tradename:
LOVENOX
Applicant:
Sanofi Aventis Us
Ingredient:
enoxaparin sodium
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 0075-0620-41 10 SYRINGE in 1 CARTON (0075-0620-41) > .4 mL in 1 SYRINGE
LOVENOX
enoxaparin sodium
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 020164 NDA sanofi-aventis U.S. LLC 0075-0620 0075-0620-40 10 SYRINGE in 1 CARTON (0075-0620-40) > .4 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Mar 29, 1993TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Jan 30, 1998TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Mar 27, 1998TE:APRLD:No

Expired Orange Book Patents for NDA: 020164

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
LOVENOX (PRESERVATIVE FREE)
enoxaparin sodium
INJECTABLE;SUBCUTANEOUS020164-007Jun 2, 20004,692,435► subscribe
Sanofi Aventis Us
LOVENOX (PRESERVATIVE FREE)
enoxaparin sodium
INJECTABLE;SUBCUTANEOUS020164-006Jun 2, 20005,389,618► subscribe
Sanofi Aventis Us
LOVENOX (PRESERVATIVE FREE)
enoxaparin sodium
INJECTABLE;SUBCUTANEOUS020164-005Mar 27, 1998RE38743► subscribe
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