Drug application

NORVASC (AMLODIPINE BESYLATE)

Drugs@FDA NDA 019787 · VIATRIS

Key facts

Drug name NORVASC
Active ingredients AMLODIPINE BESYLATE
Application type NDA
Application number 019787
Company VIATRIS
Dosage forms TABLET, ORAL
Strength EQ 2.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Jul 31, 1992

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 10–99 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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