Orange Book product

LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 200MG BASE/VIAL

Orange Book ANDA 040056 · HIKMA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name LEUCOVORIN CALCIUM PRESERVATIVE FREE
Active ingredients LEUCOVORIN CALCIUM
Strength EQ 200MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA040056
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 23, 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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