FDA.reportPublic FDA data

Application 090099

Type
ANDA
Sponsor
AM REGENT

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 44.

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
A090099-001FOSPHENYTOIN SODIUMFOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2010-05-13

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090099-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2010-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090099-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2010-05-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090099-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2010-05-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090099-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2010-05-13a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.