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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020068-001FOSCAVIRFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS1991-09-27
N020068-002FOSCAVIRFOSCARNET SODIUM12GM/500ML (24MG/ML)SOLUTION / INTRAVENOUSRLD1991-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020068-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020068-001FOSCAVIR6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS1991-09-27a50c72e98297…
2026-08-01 22:54:322026-06N020068-002FOSCAVIR12GM/500ML (24MG/ML)SOLUTION / INTRAVENOUSRLD1991-09-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020068-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FoscavirFOSCARNET SODIUMClinigen Limiteda09299d5-9c55-4cef-aed0-3a6a455322892025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020068
application number: NDA020068
ndc (product): 76310-024
FoscavirFOSCARNET SODIUMClinigen Limited90e3da4e-3b1f-428b-99ca-e4bed1c800282025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020068
application number: NDA020068
ndc (product): 76310-024

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

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