Orange Book product

PROGRAF EQ 1MG BASE

Orange Book NDA 050708 · ASTELLAS PHARMA US INC · Prescription

Key facts

Proprietary name PROGRAF
Active ingredients TACROLIMUS
Strength EQ 1MG BASE
Dosage form CAPSULE
Route ORAL
Application NDA050708
Applicant holder ASTELLAS PHARMA US INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Apr 8, 1994

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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