Drug application

AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE, VALSARTAN)

Drugs@FDA ANDA 202829 · NOVEL LABS INC

Key facts

Drug name AMLODIPINE BESYLATE AND VALSARTAN
Active ingredients AMLODIPINE BESYLATE, VALSARTAN
Application type ANDA
Application number 202829
Company NOVEL LABS INC
Dosage forms TABLET, ORAL
Strength EQ 5MG BASE;160MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 30, 2015

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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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