Orange Book product

TACROLIMUS EQ 5MG BASE

Orange Book ANDA 065461 · SANDOZ INC · Prescription

Key facts

Proprietary name TACROLIMUS
Active ingredients TACROLIMUS
Strength EQ 5MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA065461
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 10, 2009

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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