Drug application

ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE)

Drugs@FDA ANDA 086031 · WATSON LABS TEVA

Key facts

Drug name ISOSORBIDE DINITRATE
Active ingredients ISOSORBIDE DINITRATE
Application type ANDA
Application number 086031
Company WATSON LABS TEVA
Dosage forms TABLET, SUBLINGUAL
Strength 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug No
Latest submission status date Sep 29, 1987

At a glance

  • 1–9 Submissions
  • 10–99 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