Drug application

MESALAMINE (MESALAMINE)

Drugs@FDA ANDA 216967 · ALEMBIC

Key facts

Drug name MESALAMINE
Active ingredients MESALAMINE
Application type ANDA
Application number 216967
Company ALEMBIC
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 375MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Oct 28, 2022

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

Browse all Drugs@FDA applications