Drug application

NIFEDIPINE (NIFEDIPINE)

Drugs@FDA ANDA 212016 · ELITE PHARM SOLUTION

Key facts

Drug name NIFEDIPINE
Active ingredients NIFEDIPINE
Application type ANDA
Application number 212016
Company ELITE PHARM SOLUTION
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 90MG
Marketing status Prescription
TE codes AB2
Reference listed drug No
Latest submission status date Nov 18, 2020

At a glance

  • 1–9 Submissions
  • 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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