Orange Book product

TECHNETIUM TC 99M SESTAMIBI

Orange Book ANDA 078806 · JUBILANT DRAXIMAGE USA INC · Prescription

Key facts

Proprietary name TECHNETIUM TC 99M SESTAMIBI
Active ingredients TECHNETIUM TC-99M SESTAMIBI KIT
Dosage form INJECTABLE
Route INJECTION
Application ANDA078806
Applicant holder JUBILANT DRAXIMAGE USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 29, 2009

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)

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