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IC-GREEN

NDA

INDOCYANINE GREEN | N011525 | RENEW PHARMACEUTICALS LTD

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-3699 Zydus Pharmaceuticals (USA) Inc. filed this petition on August 2, 2024, requesting that the FDA determine whether IC-GREEN (indocyanine green for injection, USP) 25 mg (NDA 011525), held by Renew Pharmaceuticals Ltd., was withdrawn from the market for reasons of safety or effectiveness under 21 CFR	505(q)	2024-08-05	Withdrawn	Zydus Pharmaceuticals (USA) Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

8 trials from ClinicalTrials.gov — 8 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer NCT06583564	N/A	By Invitation	Shanghai Tong Ren Hospital	192	2024-09-27 → 2028-03-31
Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease NCT07669272	N/A	Not Yet Recruiting	Southwest Hospital, China	59	2026-10-01 → 2029-09-30
Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients NCT07658768	Early Phase 1	Not Yet Recruiting	Abramson Cancer Center at Penn Medicine	20	2026-09-01 → 2027-05-01
Fluorescence-Guided Optimization of Sarcoma Margins NCT07134192	N/A	Recruiting	University of Aarhus	90	2025-09-01 → 2028-03-01
UHFUS Characterization of Normal Lymphatic Anatomy NCT07677839	N/A	Recruiting	University of California, Davis	50	2026-06-17 → 2036-09-01
Study of the Brain's Natural Cleaning System in Potential Organ Donors.NCT07682155	N/A	Recruiting	Germans Trias i Pujol Hospital	10	2026-02-01 → 2026-12-31
Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial NCT07650656	Phase 2	Recruiting	City of Hope Medical Center	22	2027-05-15 → 2028-05-11
Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer NCT07146295	N/A	Recruiting	Isabelle Henskens	1,760	2025-04-18 → 2026-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

WEYLCHEM ORGANICA GMBHINDOCYANINE GREEN DRUG SUBSTANCE

DMF 196012006

BIOPHORE INDIA PHARMACEUTICALS PVT LTDINDOCYANINE GREEN

DMF 366472021

ICROM SRLINDOCYANINE GREEN

DMF 381042023

MACSEN DRUGSINDOCYANINE GREEN USP

DMF 401642024

NANTONG JINGHUA PHARMACEUTICAL CO LTDINDOCYANINE GREEN

DMF 406052024

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDINDOCYANINE GREEN USP

DMF 430852025

DISTILLATION PROD INDS DIV EASTMAN KODAK COInactiveINDOCYANINE GREEN

DMF 2941958

PCASInactiveINDOCYANINE GREEN

DMF 194232006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 24, 2026	SUPPL -43	View Letter (PDF)
Dec 6, 2024	SUPPL -39	View Letter (PDF)
Feb 9, 2023	SUPPL -31	View Letter (PDF)
Sep 27, 2006	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

RENEW PHARMS changed IC-GREEN (indocyanine green) NDA 011525 status from discontinued to prescription drug product.

Old: DISCN

New: RX

MODIFIEDrs7/1/2026

RENEW PHARMS added reporting of Repackager/Reshipper activity to the IC-GREEN (indocyanine green) NDA 011525 supplement 003 record in Drugs@FDA.

Old: No

New: Yes