APPLICATION
NDA011525
TYPE
NDA
ORIGINAL APPROVAL
1959-02-09
LATEST ACTION
2026-04-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
IC-GREENPrescription
INDOCYANINE GREEN 10MG/VIAL · INJECTABLE · INJECTION
IC-GREEN · ReferencePrescription
INDOCYANINE GREEN 25MG/VIAL · INJECTABLE · INJECTION
IC-GREENDiscontinued
INDOCYANINE GREEN 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
IC-GREENDiscontinued
INDOCYANINE GREEN 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1998-03-02Manufacturing (CMC) · Supplement 15 · priorityAP
1997-10-21Manufacturing (CMC) · Supplement 14 · priorityAP
1995-03-30Manufacturing (CMC) · Supplement 13 · priorityAP
1995-03-30Manufacturing (CMC) · Supplement 12 · priorityAP
1991-06-05Labeling · Supplement 11AP
1989-08-02Manufacturing (CMC) · Supplement 9 · priorityAP
1959-02-09Type 1 - New Molecular Entity · Original · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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