Orange Book product

KETOROLAC TROMETHAMINE 30MG/ML

Orange Book ANDA 074802 · HOSPIRA INC · Prescription

Key facts

Proprietary name KETOROLAC TROMETHAMINE
Active ingredients KETOROLAC TROMETHAMINE
Strength 30MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA074802
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jun 5, 1997

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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