Orange Book product

RISPERDAL 5MG

Orange Book NDA 020272 · JANSSEN PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name RISPERDAL
Active ingredients RISPERIDONE
Strength 5MG
Dosage form TABLET
Route ORAL
Application NDA020272
Applicant holder JANSSEN PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 29, 1993

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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