Drug application

DILATRATE-SR (ISOSORBIDE DINITRATE)

Drugs@FDA NDA 019790 · ENDO OPERATIONS

Key facts

Drug name DILATRATE-SR
Active ingredients ISOSORBIDE DINITRATE
Application type NDA
Application number 019790
Company ENDO OPERATIONS
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 40MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Sep 2, 1988

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 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 · Source date:

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