Orange Book product

LOVENOX 300MG/3ML (100MG/ML)

Orange Book NDA 020164 · SANOFI AVENTIS US LLC · Prescription

Key facts

Proprietary name LOVENOX
Active ingredients ENOXAPARIN SODIUM
Strength 300MG/3ML (100MG/ML)
Dosage form INJECTABLE
Route INTRAVENOUS, SUBCUTANEOUS
Application NDA020164
Applicant holder SANOFI AVENTIS US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 23, 2003

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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