Orange Book product

PREVACID 30MG

Orange Book NDA 021428 · TAKEDA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name PREVACID
Active ingredients LANSOPRAZOLE
Strength 30MG
Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route ORAL
Application NDA021428
Applicant holder TAKEDA PHARMACEUTICALS USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Aug 30, 2002

At a glance

  • 1–9 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)

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