Drug application

NIFEDIPINE (NIFEDIPINE)

Drugs@FDA ANDA 075269 · VALEANT PHARMS NORTH

Key facts

Drug name NIFEDIPINE
Active ingredients NIFEDIPINE
Application type ANDA
Application number 075269
Company VALEANT PHARMS NORTH
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 30MG
Marketing status Prescription
TE codes AB1
Reference listed drug No
Latest submission status date Dec 4, 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
  • Yes 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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