Drug application

INDOMETHACIN (INDOMETHACIN)

Drugs@FDA ANDA 201807 · HETERO LABS LTD III

Key facts

Drug name INDOMETHACIN
Active ingredients INDOMETHACIN
Application type ANDA
Application number 201807
Company HETERO LABS LTD III
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 75MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Sep 28, 2012

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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