Orange Book product

LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL

Orange Book ANDA 217021 · HAINAN POLY PHARM CO LTD · Prescription

Key facts

Proprietary name LEUCOVORIN CALCIUM
Active ingredients LEUCOVORIN CALCIUM
Strength EQ 500MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA217021
Applicant holder HAINAN POLY PHARM CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 10, 2023

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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