Orange Book product

KLONOPIN 0.125MG **Federal Register determination that product was…

Orange Book NDA 017533 · CHEPLAPHARM ARZNEIMITTEL GMBH · Discontinued

Key facts

Proprietary name KLONOPIN
Active ingredients CLONAZEPAM
Strength 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form TABLET
Route ORAL
Application NDA017533
Applicant holder CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 9, 1997

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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