Orange Book product

LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 350MG BASE/VIAL

Orange Book ANDA 200855 · SAGENT PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name LEUCOVORIN CALCIUM PRESERVATIVE FREE
Active ingredients LEUCOVORIN CALCIUM
Strength EQ 350MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA200855
Applicant holder SAGENT PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 6, 2012

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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