FDA.reportPublic FDA data

Application 077174

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSCARNET SODIUMFOSCARNET SODIUMINJECTABLE;INJECTION2.4GM/100MLNoNo
002FOSCARNET SODIUMFOSCARNET SODIUMSOLUTION;INTRAVENOUS12GM/500ML (24MG/ML)NoNo

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
A077174-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUS2005-05-31
A077174-002FOSCARNET SODIUMFOSCARNET SODIUM12GM/500ML (24MG/ML)SOLUTION / INTRAVENOUS2005-05-31

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 22:54:322026-06A077174-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUS2005-05-31a50c72e98297…
2026-08-01 22:54:322026-06A077174-002FOSCARNET SODIUM12GM/500ML (24MG/ML)SOLUTION / INTRAVENOUS2005-05-31a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foscarnet SodiumFOSCARNET SODIUMAmneal Pharmaceuticals LLCb03cbb8e-f555-4ed3-854e-dd962604f1442026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Foscarnet Sodium
generic name: FOSCARNET SODIUM
Foscarnet SodiumFOSCARNET SODIUMCaplin Steriles Limited6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a952026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Foscarnet Sodium
generic name: FOSCARNET SODIUM
FoscavirFOSCARNET SODIUMClinigen Limiteda09299d5-9c55-4cef-aed0-3a6a455322892025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FOSCARNET SODIUM
FoscavirFOSCARNET SODIUMClinigen Limited90e3da4e-3b1f-428b-99ca-e4bed1c800282025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FOSCARNET SODIUM
foscarnet sodiumFOSCARNET SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d2b4ce68-5a81-4b14-8914-21bc38f010082025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: foscarnet sodium
generic name: FOSCARNET SODIUM
Foscarnet SodiumFOSCARNET SODIUMHikma Pharmaceuticals USA Inc.b612e6f1-584f-4188-b96e-1a9adfcfe75c2024-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Foscarnet Sodium
generic name: FOSCARNET SODIUM
FOSCARNET SODIUMFOSCARNET SODIUMBaxter Healthcare Corporation8a7caffd-9d8a-4d45-ad48-70d511a89c292023-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FOSCARNET SODIUM
generic name: FOSCARNET SODIUM
FoscarnetFOSCARNET SODIUMFresenius Kabi USA, LLC335f7deb-a045-43cb-b319-d7b73bfda73c2021-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FOSCARNET SODIUM
Foscarnet SodiumFOSCARNET SODIUMGland Pharma Limitedd4048736-389f-48d8-aadd-6bc76d604ddb2021-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Foscarnet Sodium
generic name: FOSCARNET SODIUM
Foscarnet SodiumFOSCARNET SODIUMSagent Pharmaceuticals2f49c1bc-0828-4e5c-a3c0-81e997213b0e2021-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Foscarnet Sodium
generic name: FOSCARNET SODIUM

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9015ORIG2005-06-07