Drug application

AFEDITAB CR (NIFEDIPINE)

Drugs@FDA ANDA 075128 · WATSON LABS TEVA

Key facts

Drug name AFEDITAB CR
Active ingredients NIFEDIPINE
Application type ANDA
Application number 075128
Company WATSON LABS TEVA
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 30MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Mar 10, 2000

At a glance

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