Orange Book product

AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL

Orange Book ANDA 074419 · HIKMA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name AZATHIOPRINE SODIUM
Active ingredients AZATHIOPRINE SODIUM
Strength EQ 100MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA074419
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Mar 31, 1995

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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