Orange Book product

PREVACID 15MG **Federal Register determination that product was not…

Orange Book NDA 020406 · TAKEDA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name PREVACID
Active ingredients LANSOPRAZOLE
Strength 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form CAPSULE, DELAYED REL PELLETS
Route ORAL
Application NDA020406
Applicant holder TAKEDA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date May 10, 1995

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Browse all Orange Book products