FDA.reportPublic FDA data

Application 078476

Type
ANDA
Sponsor
AMNEAL

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
A078476-001FOSPHENYTOIN SODIUMFOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2008-03-18

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 UTC2022-10A078476-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2008-03-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078476-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2008-03-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078476-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2008-03-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078476-001FOSPHENYTOIN SODIUMEQ 50MG PHENYTOIN NA/MLINJECTABLE / INJECTION2008-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078476-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A078476-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078476-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078476-001AP1ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosphenytoin SodiumFOSPHENYTOIN SODIUMAmneal Pharmaceuticals LLC87ff8a91-5b37-401c-b75c-dc6efd3487612024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078476
application number: ANDA078476
ndc (product): 65162-998
ndc (product): 65162-999

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-998Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-998Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-998Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-999Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-999Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-999Fosphenytoin SodiumFosphenytoin SodiumAmneal Pharmaceuticals of New York, LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal BiosciencesANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1381Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal BiosciencesANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent
70121-1390Fosphenytoin SodiumFosphenytoinAmneal Pharmaceuticals LLCANDACurrent