Orange Book product

CLOZARIL 200MG **Federal Register determination that product was not…

Orange Book NDA 019758 · HERITAGE LIFE SCIENCES BARBADOS INC · Discontinued

Key facts

Proprietary name CLOZARIL
Active ingredients CLOZAPINE
Strength 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form TABLET
Route ORAL
Application NDA019758
Applicant holder HERITAGE LIFE SCIENCES BARBADOS INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date May 20, 2019

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)

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