Drug application

PREVACID (LANSOPRAZOLE)

Drugs@FDA NDA 021428 · TAKEDA PHARMS USA

Key facts

Drug name PREVACID
Active ingredients LANSOPRAZOLE
Application type NDA
Application number 021428
Company TAKEDA PHARMS USA
Dosage forms TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, ORAL
Strength 15MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Aug 30, 2002

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 10–99 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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