Orange Book product

INDOCYANINE GREEN 25MG/VIAL

Orange Book ANDA 040811 · RENEW PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name INDOCYANINE GREEN
Active ingredients INDOCYANINE GREEN
Strength 25MG/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA040811
Applicant holder RENEW PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Nov 21, 2007

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)

Browse all Orange Book products