Drug application

INDOMETHACIN (INDOMETHACIN)

Drugs@FDA ANDA 216184 · ZYDUS LIFESCIENCES

Key facts

Drug name INDOMETHACIN
Active ingredients INDOMETHACIN
Application type ANDA
Application number 216184
Company ZYDUS LIFESCIENCES
Dosage forms SUPPOSITORY, RECTAL
Strength 50MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 2, 2023

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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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