Drug application

METHOTREXATE SODIUM (METHOTREXATE SODIUM)

Drugs@FDA NDA 008085 · STRIDES PHARMA INTL

Key facts

Drug name METHOTREXATE SODIUM
Active ingredients METHOTREXATE SODIUM
Application type NDA
Application number 008085
Company STRIDES PHARMA INTL
Dosage forms TABLET, ORAL
Strength EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Dec 7, 1953

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None 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 · Source date:

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