FDA.reportPublic FDA data

Application 078158

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSPHENYTOIN SODIUMFOSPHENYTOIN SODIUMINJECTABLE;INJECTIONEQ 50MG PHENYTOIN NA/MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078158-001FOSPHENYTOIN SODIUMFOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2007-08-06

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 22:54:322026-06A078158-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2007-08-06a50c72e98297…

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
Fosphenytoin sodiumFOSPHENYTOIN SODIUMGLENMARK PHARMACEUTICALS INC., USAa0def32c-e693-43e5-9509-0cef9642441c2026-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin sodium
generic name: FOSPHENYTOIN SODIUM
Fosphenytoin sodiumFOSPHENYTOIN SODIUMGLENMARK PHARMACEUTICALS INC., USAbb38bc6a-99c7-4cda-b3f0-37f629d060cf2026-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin sodium
generic name: FOSPHENYTOIN SODIUM
CEREBYXFOSPHENYTOIN SODIUMPfizer Laboratories Div Pfizer Incd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a2025-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FOSPHENYTOIN SODIUM
CEREBYXFOSPHENYTOIN SODIUMPfizer Laboratories Div Pfizer Incde5a6711-4abb-4c3d-a18b-266b094ace112025-05-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FOSPHENYTOIN SODIUM
Fosphenytoin SodiumFOSPHENYTOIN SODIUMSagent Pharmaceuticalse1dab8ad-cbf6-4273-92fa-02629de2abde2024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin Sodium
generic name: FOSPHENYTOIN SODIUM
Fosphenytoin SodiumFOSPHENYTOIN SODIUMAmneal Pharmaceuticals LLC87ff8a91-5b37-401c-b75c-dc6efd3487612024-10-25Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin Sodium
generic name: FOSPHENYTOIN SODIUM
Fosphenytoin SodiumFOSPHENYTOIN SODIUMHikma Pharmaceuticals USA Inc.519a44e3-8a93-456c-b71c-894513810d452024-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin Sodium
generic name: FOSPHENYTOIN SODIUM
Fosphenytoin sodiumFOSPHENYTOIN SODIUMGland Pharma Limited49b08648-6a83-42c7-ae7b-80c29f2534fc2023-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin sodium
generic name: FOSPHENYTOIN SODIUM
FosphenytoinFOSPHENYTOIN SODIUMFresenius Kabi USA, LLCb60c9c82-e5c7-4e05-98c7-5bbba4af04b22023-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FOSPHENYTOIN SODIUM
Fosphenytoin SodiumFOSPHENYTOIN SODIUMWest-Ward Pharmaceuticals Corpc92df63b-5140-4213-8d43-8327ff6230b72018-01-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fosphenytoin Sodium
generic name: FOSPHENYTOIN SODIUM

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18476ORIG2007-08-07
9125ORIG2007-08-07