Orange Book product

ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE

Orange Book ANDA 218875 · CREEKWOOD PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name ATOMOXETINE HYDROCHLORIDE
Active ingredients ATOMOXETINE HYDROCHLORIDE
Strength EQ 18MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA218875
Applicant holder CREEKWOOD PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 16, 2026

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)

Browse all Orange Book products