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INDOCYANINE GREEN

ANDA

INDOCYANINE GREEN | A040811 | RENEW PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: IC-GREEN(TE code: AP)

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

1 letter from Drugs@FDA

Date	Submission	Document
Nov 26, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 21, 2007

No patent or exclusivity listings for this strength.