Orange Book product

RILUZOLE 50MG

Orange Book ANDA 206045 · KENTON CHEMICALS AND PHARMACEUTICALS CORP · Prescription

Key facts

Proprietary name RILUZOLE
Active ingredients RILUZOLE
Strength 50MG
Dosage form TABLET
Route ORAL
Application ANDA206045
Applicant holder KENTON CHEMICALS AND PHARMACEUTICALS CORP
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 9, 2019

At a glance

  • 1–9 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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