Drug application

ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE)

Drugs@FDA ANDA 076813 · HIKMA INTL PHARMS

Key facts

Drug name ISOSORBIDE MONONITRATE
Active ingredients ISOSORBIDE MONONITRATE
Application type ANDA
Application number 076813
Company HIKMA INTL PHARMS
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 60MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jan 7, 2005

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None 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

Browse all Drugs@FDA applications