Orange Book product

ATORVASTATIN CALCIUM EQ 20MG BASE

Orange Book ANDA 214969 · APOTEX INC · Prescription

Key facts

Proprietary name ATORVASTATIN CALCIUM
Active ingredients ATORVASTATIN CALCIUM
Strength EQ 20MG BASE
Dosage form TABLET
Route ORAL
Application ANDA214969
Applicant holder APOTEX INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 2, 2021

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)

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