Orange Book product

ATENOLOL AND CHLORTHALIDONE 100MG;25MG

Orange Book ANDA 213302 · UNICHEM LABORATORIES LTD · Prescription

Key facts

Proprietary name ATENOLOL AND CHLORTHALIDONE
Active ingredients ATENOLOL, CHLORTHALIDONE
Strength 100MG;25MG
Dosage form TABLET
Route ORAL
Application ANDA213302
Applicant holder UNICHEM LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Nov 25, 2020

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