Orange Book product

METHOTREXATE PRESERVATIVE FREE EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register…

Orange Book NDA 011719 · HOSPIRA INC · Discontinued

Key facts

Proprietary name METHOTREXATE PRESERVATIVE FREE
Active ingredients METHOTREXATE SODIUM
Strength EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form INJECTABLE
Route INJECTION
Application NDA011719
Applicant holder HOSPIRA INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Apr 13, 2005

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 10–99 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)

Browse all Orange Book products