FDA.reportPublic FDA data

Application 219773

Type
ANDA
Sponsor
MANKIND PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL100MG EXTENDEDNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219773-001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORAL2026-01-02

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
2026-09-14 22:38:342026-08A219773-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORAL2026-01-0284e616aacf4f…
2026-08-18 06:07:402026-07A219773-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORAL2026-01-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219773-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2026-01-02011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219773-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2026-01-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219773-001AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219773-001AB1a50c72e98297…

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenytekEXTENDED PHENYTOIN SODIUMMylan Pharmaceuticals Inc.0f94c791-8b07-4b41-927e-c9f28bec5f602024-10-15Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUMPHENYTOIN SODIUMAcella Pharmaceuticals, LLC6922f32f-8bed-4c09-8103-27987bcbd1042024-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMA-S Medication Solutionsd4459837-da26-4c97-8587-32eb1f682d582024-05-22Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMHikma Pharmaceuticals USA Inc.035a8d4e-2063-4240-83cb-d7eebcabe3012024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMHikma Pharmaceuticals USA Inc.8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e72024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUMPHENYTOIN SODIUMHF Acquisition Co LLC, DBA HealthFirst7607ddff-2f1c-272c-e053-2991aa0a1ab32024-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMMedical Purchasing Solutions, LLC0aac9dcd-c4df-84d9-e063-6294a90a03762023-11-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Extended Phenytoin SodiumPHENYTOIN SODIUMAurobindo Pharma Limited5362ea50-38a4-48b4-a85b-d634c3d8b91a2023-09-21Warnings, Adverse reactionsName fallback
brand name: Extended Phenytoin Sodium
generic name: PHENYTOIN SODIUM
phenytoin sodiumPHENYTOIN SODIUMSun Pharmaceutical Industries, Inc.c40f66cc-6f4a-4b29-84ba-d265e48487352022-12-14Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUMPHENYTOIN SODIUMHF Acquisition Co LLC, DBA HealthFirst763b549d-9b78-09dd-e053-2a91aa0aec7f2022-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM
Phenytoin SodiumPHENYTOIN SODIUMUnichem Pharmaceuticals (USA), Inc.afdf66e0-5f99-444e-bc06-2fdddc507f5c2022-10-19Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN SODIUM

Reported adverse events (FAERS/openFDA)#

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