FDA.reportPublic FDA data

Application 020068

Type
NDA
Sponsor
CLINIGEN HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSCAVIRFOSCARNET SODIUMINJECTABLE;INJECTION2.4GM/100MLYesYes
002FOSCAVIRFOSCARNET SODIUMSOLUTION;INTRAVENOUS12GM/500ML (24MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Healthcare Ltd.NDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024FoscavirFOSCARNET SODIUMClinigen LimitedNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024FoscavirFOSCARNET SODIUMClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen LimitedNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen LimitedNDACurrent
76310-024FoscavirFOSCARNET SODIUMClinigen Group PLCNDACurrent
76310-024Foscavirfoscarnet sodiumClinigen Healthcare Ltd.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65488SUPPL2020-12-02
65373SUPPL2020-11-30
47432SUPPL2017-03-02
47336SUPPL2017-02-27
45893SUPPL2016-11-15
45889SUPPL2016-11-14
12177SUPPL2015-05-05
21103SUPPL2014-11-12
34234SUPPL2012-04-06
34233SUPPL2007-12-03
21102SUPPL2006-05-18
34232SUPPL2006-05-16