Drug application

AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)

Drugs@FDA ANDA 078081 · SUN PHARM INDUSTRIES

Key facts

Drug name AMLODIPINE BESYLATE
Active ingredients AMLODIPINE BESYLATE
Application type ANDA
Application number 078081
Company SUN PHARM INDUSTRIES
Dosage forms TABLET, ORAL
Strength EQ 2.5MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jan 31, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None 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

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