Orange Book product

LOVENOX (PRESERVATIVE FREE) 80MG/0.8ML (100MG/ML)

Orange Book NDA 020164 · SANOFI AVENTIS US LLC · Prescription

Key facts

Proprietary name LOVENOX (PRESERVATIVE FREE)
Active ingredients ENOXAPARIN SODIUM
Strength 80MG/0.8ML (100MG/ML)
Dosage form INJECTABLE
Route SUBCUTANEOUS
Application NDA020164
Applicant holder SANOFI AVENTIS US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Mar 27, 1998

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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