FDA.reportPublic FDA data

Application 089744

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOIN SODIUMPHENYTOIN SODIUMINJECTABLE;INJECTION50MG/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
A089744-001PHENYTOIN SODIUMPHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTION1987-12-18

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A089744-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTION1987-12-18a50c72e98297…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenytoin SodiumPHENYTOIN SODIUMA-S Medication Solutionsef4e97a7-cd18-47a9-a016-2eca5481a87e2026-07-24Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Extended Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.363cd347-d25e-42b9-9ce7-30642f3cb3532026-06-25Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Extended Phenytoin SodiumPHENYTOIN SODIUMAmneal Pharmaceuticals LLC7e467c02-49a0-4b62-b537-430fdfa4f10e2026-05-26Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.e33ce05d-9c60-4ede-8b13-e8c41a3de25d2026-05-19Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMCoupler LLC51b660c3-7d88-77b2-e063-6294a90a02862026-05-13Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMGolden State Medical Supply, Inc.36262a4c-33f1-40a5-e063-6394a90ad36a2026-04-21Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.844a16db-17d5-44da-819d-54f3e19cfec22026-03-25Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMSun Pharmaceutical Industries, Inc.601f7353-225d-4a5d-9810-3869c2c218742026-03-17Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMAvPAK4c2542b8-ac54-e85d-e063-6294a90a759b2026-03-03Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUMPHENYTOIN SODIUMDIRECT RXdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2142026-02-27Warnings, Adverse reactionsName fallback
brand name: PHENYTOIN SODIUM
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMProficient Rx LPf4353734-29b0-4027-824d-2fc97f778c672026-02-01Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMMajor Pharmaceuticals46d5c0d1-a97b-46d9-8cf4-9947806733372025-12-09Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMProPharma Distribution43060ca9-58a7-3371-e063-6294a90a57992025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMHenry Schein, Inc.889dd22c-46f0-48d0-b18e-a3783c5fa6532025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMAphena Pharma Solutions - Tennessee, LLC3bc82d23-3950-f181-e063-6394a90ad5652025-09-02Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Extended Phenytoin SodiumPHENYTOIN SODIUMBryant Ranch Prepacka9a1059e-63a2-486e-aa50-eda388f795252025-06-11Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Extended Phenytoin SodiumPHENYTOIN SODIUMAmerican Health Packaging5b64cb11-673a-41ec-9b2a-1e194ae5eb0c2025-02-06Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUMPHENYTOIN SODIUMHenry Schein, Inc.a52cf1bd-dc1f-47be-aba8-29066d9a50fb2024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PHENYTOIN SODIUM
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMAphena Pharma Solutions - Tennessee, LLC29b8d0a2-a96e-46a5-e063-6394a90a71132024-12-20Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMBryant Ranch Prepack6b4c2885-eae0-4c88-ada3-62a699df1dbb2024-11-01Warnings, Adverse reactionsName fallback
brand name: Phenytoin Sodium
generic name: PHENYTOIN SODIUM