Orange Book product

PAXIL EQ 10MG BASE

Orange Book NDA 020031 · APOTEX INC · Prescription

Key facts

Proprietary name PAXIL
Active ingredients PAROXETINE HYDROCHLORIDE
Strength EQ 10MG BASE
Dosage form TABLET
Route ORAL
Application NDA020031
Applicant holder APOTEX INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Dec 29, 1992

At a glance

  • 1–9 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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