Orange Book product

ARICEPT 5MG

Orange Book NDA 020690 · EISAI INC · Prescription

Key facts

Proprietary name ARICEPT
Active ingredients DONEPEZIL HYDROCHLORIDE
Strength 5MG
Dosage form TABLET
Route ORAL
Application NDA020690
Applicant holder EISAI INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Nov 25, 1996

At a glance

  • 10–99 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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