Orange Book product

QUETIAPINE FUMARATE EQ 200MG BASE

Orange Book ANDA 204316 · HETERO LABS LTD UNIT V · Prescription

Key facts

Proprietary name QUETIAPINE FUMARATE
Active ingredients QUETIAPINE FUMARATE
Strength EQ 200MG BASE
Dosage form TABLET
Route ORAL
Application ANDA204316
Applicant holder HETERO LABS LTD UNIT V
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 16, 2022

At a glance

  • 10–99 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