Drug application

AMVAZ (AMLODIPINE MALEATE)

Drugs@FDA NDA 021435 · DR REDDYS LABS INC

Key facts

Drug name AMVAZ
Active ingredients AMLODIPINE MALEATE
Application type NDA
Application number 021435
Company DR REDDYS LABS INC
Dosage forms TABLET, ORAL
Strength 2.5MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Oct 31, 2003

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

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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