Orange Book product

ISOVUE-370 76%

Orange Book NDA 018735 · BRACCO DIAGNOSTICS INC · Prescription

Key facts

Proprietary name ISOVUE-370
Active ingredients IOPAMIDOL
Strength 76%
Dosage form INJECTABLE
Route INJECTION
Application NDA018735
Applicant holder BRACCO DIAGNOSTICS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Dec 31, 1985

At a glance

  • 1–9 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)

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