Drug application

ENALAPRIL MALEATE (ENALAPRIL MALEATE)

Drugs@FDA ANDA 075459 · SANDOZ INC

Key facts

Drug name ENALAPRIL MALEATE
Active ingredients ENALAPRIL MALEATE
Application type ANDA
Application number 075459
Company SANDOZ INC
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 22, 2000

At a glance

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