Orange Book product

METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

Orange Book ANDA 040263 · FRESENIUS KABI USA LLC · Discontinued

Key facts

Proprietary name METHOTREXATE SODIUM
Active ingredients METHOTREXATE SODIUM
Strength EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Dosage form INJECTABLE
Route INJECTION
Application ANDA040263
Applicant holder FRESENIUS KABI USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 26, 1999

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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