FDA.reportPublic FDA data

Application 089892

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOINPHENYTOINSUSPENSION;ORAL125MG/5MLNoNo

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
A089892-001PHENYTOINPHENYTOIN125MG/5MLSUSPENSION / ORAL1992-09-25

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A089892-001PHENYTOIN125MG/5MLSUSPENSION / ORAL1992-09-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089892-001PHENYTOIN125MG/5MLSUSPENSION / ORAL1992-09-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089892-001PHENYTOIN125MG/5MLSUSPENSION / ORAL1992-09-25a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenytoin InfatabsPHENYTOINPrasco Laboratories3580e6a8-f7c3-44a0-a1eb-2a84ae589d212026-05-22Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN
PhenytoinPHENYTOINREMEDYREPACK INC.31e8a777-75b1-4f48-9682-0bcc3189ad262026-05-19Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
Dilantin InfatabsPHENYTOINParke-Davis Div of Pfizer Incca119a89-2394-4d34-8078-cd1fa4e8e2f12026-05-12Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN
PhenytoinPHENYTOINMajor Pharmaceuticals08a9d26b-4419-43ec-98f3-43d4534c2e762026-04-29Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINSun Pharmaceutical Industries, Inc.78b38e7b-1460-4adc-b738-320ffa6259c22026-03-27Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINNCS HealthCare of KY, LLC dba Vangard Labs98bd1d9f-b1a4-49eb-a0b4-a790265710dd2026-02-25Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINAmerican Health Packagingf9fe4c92-2761-4cb4-9cf3-7066e240e0142025-09-17Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINSun Pharmaceutical Industries, Inc.093fd736-5971-47af-b4ef-08c1696cebe82025-08-19Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINATLANTIC BIOLOGICALS CORP.09daf485-3355-44cb-92af-072dd281e1292025-05-28Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINMylan Pharmaceuticals Inc.37943ec1-a8d2-42df-967e-6f96f84c017b2024-12-24Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINPAI Holdings, LLC dba PAI Pharmaf2c74e35-ed8d-4ea6-b7a5-7be0b0155c152024-11-19Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
PhenytoinPHENYTOINAmerican Health Packaging352007dd-0587-4597-8338-c13eda4c5d632024-10-03Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
Phenytoin InfatabsPHENYTOINNCS HealthCare of KY, LLC dba Vangard Labs0d240b2b-bc5c-4989-a20b-54ed37a09a4f2024-04-11Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN
PhenytoinPHENYTOINRising Pharma Holdings, Inc.e95cad66-b5f9-4802-a35f-fed340bf09ab2024-03-14Warnings, Adverse reactionsName fallback
brand name: Phenytoin
generic name: PHENYTOIN
Dilantin-125PHENYTOINViatris Specialty LLCf339f9e4-b289-4efe-82b9-46c57d1dc2772023-02-02Warnings, Adverse reactionsName fallback
generic name: PHENYTOIN

Reported adverse events (FAERS/openFDA)#

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