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Details for New Drug Application (NDA): 040811

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NDA 040811 describes INDOCYANINE GREEN, which is a drug marketed by Diagnostic Green and is included in one NDA. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.

Summary for NDA: 040811

Diagnostic Green
indocyanine green

Pharmacology for NDA: 040811

Mechanism of ActionDyes

Suppliers and Packaging for NDA: 040811

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
indocyanine green
INJECTABLE;INJECTION 040811 ANDA HUB Pharmaceuticals LLC 17238-424 17238-424-02 1 KIT in 1 CARTON (17238-424-02)
indocyanine green
INJECTABLE;INJECTION 040811 ANDA PULSION Medical Systems SE 25431-424 25431-424-02 1 KIT in 1 CARTON (25431-424-02)

Summary for product number 001

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

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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 verifification 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.