Drug application

METHOTREXATE SODIUM (METHOTREXATE SODIUM)

Drugs@FDA ANDA 216453 · ELITE LABS INC

Key facts

Drug name METHOTREXATE SODIUM
Active ingredients METHOTREXATE SODIUM
Application type ANDA
Application number 216453
Company ELITE LABS INC
Dosage forms TABLET, ORAL
Strength EQ 2.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 16, 2024

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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