Drug application

MONTELUKAST SODIUM (MONTELUKAST SODIUM)

Drugs@FDA ANDA 202859 · PHARMOBEDIENT

Key facts

Drug name MONTELUKAST SODIUM
Active ingredients MONTELUKAST SODIUM
Application type ANDA
Application number 202859
Company PHARMOBEDIENT
Dosage forms TABLET, ORAL
Strength EQ 10MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Oct 30, 2014

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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