Drug application

AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)

Drugs@FDA ANDA 076846 · TEVA

Key facts

Drug name AMLODIPINE BESYLATE
Active ingredients AMLODIPINE BESYLATE
Application type ANDA
Application number 076846
Company TEVA
Dosage forms TABLET, ORAL
Strength EQ 2.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 28, 2007

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None 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

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