FDA.reportPublic FDA data

Application 040811

Type
ANDA
Sponsor
DIAGNOSTIC GREEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOCYANINE GREENINDOCYANINE GREENINJECTABLE;INJECTION25MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17238-424Indocyanine GreenIndocyanine Green and WaterHUB Pharmaceuticals LLCANDACurrent
17238-424Indocyanine GreenIndocyanine Green and WaterHUB Pharmaceuticals LLCANDACurrent
17238-424Indocyanine GreenIndocyanine Green and WaterHUB Pharmaceuticals LLCANDACurrent
17238-424Indocyanine GreenIndocyanine Green and WaterHUB Pharmaceuticals LLCANDACurrent
17238-424Indocyanine GreenIndocyanine Green and WaterHUB Pharmaceuticals LLCANDACurrent
17238-424Indocyanine GreenIndocyanine Green and WaterHUB Pharmaceuticals LLCANDACurrent
49673-424Indocyanine greenIndocyanine greenNovadaq Technologies Inc.ANDACurrent
66259-424Indocyanine greenIndocyanine greenNovadaq Technologies Inc.ANDACurrent
70100-424Indocyanine GreenIndocyanine Green and WaterDiagnostic Green GmbHANDACurrent
70100-424Indocyanine GreenIndocyanine Green and WaterDiagnostic Green GmbHANDACurrent
70100-424Indocyanine GreenIndocyanine Green and WaterRenew Pharmaceuticals LimitedANDACurrent
70100-424Indocyanine GreenIndocyanine Green and WaterDiagnostic Green GmbHANDACurrent
70100-424Indocyanine GreenIndocyanine Green and WaterRenew Pharmaceuticals LimitedANDACurrent
70599-424ICGIndocyanine Green and WaterKARL STORZ Endoscopy-America, Inc.ANDACurrent
70599-424ICGIndocyanine Green and WaterKARL STORZ Endoscopy-America, Inc.ANDACurrent
73624-424Indocyanine GreenIndocyanine Green and WaterOlympus America, Inc.ANDACurrent
75874-424Indocyanine greenIndocyanine greenNovadaq Technologies Inc.ANDACurrent
75874-820Indocyanine greenIndocyanine greenNovadaq Technologies Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7680ORIG2007-11-26