Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Baxter
Moodys
Harvard Business School
Dow

Last Updated: October 7, 2022

Details for New Drug Application (NDA): 040811


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 040811 describes INDOCYANINE GREEN, which is a drug marketed by Renew Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the INDOCYANINE GREEN profile page.

The generic ingredient in INDOCYANINE GREEN is indocyanine green. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
Summary for 040811
Tradename:INDOCYANINE GREEN
Applicant:Renew Pharms
Ingredient:indocyanine green
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040811
Suppliers and Packaging for NDA: 040811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOCYANINE GREEN indocyanine green INJECTABLE;INJECTION 040811 ANDA HUB Pharmaceuticals LLC 17238-424 17238-424-02 1 KIT in 1 CARTON (17238-424-02)
INDOCYANINE GREEN indocyanine green INJECTABLE;INJECTION 040811 ANDA Renew Pharmaceuticals Limited 70100-424 70100-424-02 6 PACKAGE in 1 CARTON (70100-424-02) > 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/VIAL
Approval Date:Nov 21, 2007TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Express Scripts
McKesson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.