Orange Book product

HEPARIN SODIUM 1,000 UNITS/ML

Orange Book NDA 017037 · HIKMA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name HEPARIN SODIUM
Active ingredients HEPARIN SODIUM
Strength 1,000 UNITS/ML
Dosage form INJECTABLE
Route INJECTION
Application NDA017037
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 1, 1982

At a glance

  • 10–99 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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