FDA.reportPublic FDA data

Application 081306

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETHOSUXIMIDEETHOSUXIMIDESYRUP;ORAL250MG/5MLNoNo

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
A081306-001ETHOSUXIMIDEETHOSUXIMIDE250MG/5MLSYRUP / ORAL1993-07-30

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 22:54:322026-06A081306-001ETHOSUXIMIDE250MG/5MLSYRUP / ORAL1993-07-30a50c72e98297…

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EthosuximideETHOSUXIMIDEMylan Pharmaceuticals Inc.19c924c2-f558-4c78-9277-2d7e0df2f5052026-07-24Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
ETHOSUXIMIDEETHOSUXIMIDEStrides Pharma Science Limiteda4dbc665-4db1-4d0a-9630-5cd200ec4c822026-06-25Warnings, Adverse reactionsName fallback
brand name: ETHOSUXIMIDE
generic name: ETHOSUXIMIDE
EthosuximideETHOSUXIMIDEChartwell Governmental & Specialty RX, LLC.a825265d-ace9-4463-a16d-f6d5e1e311882026-06-11Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
EthosuximideETHOSUXIMIDEChartwell RX, LLC9812840a-004d-46fa-8414-7d04a384e06a2026-05-28Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
ZarontinETHOSUXIMIDEParke-Davis Div of Pfizer Inc0e008f33-70a1-4bc6-b3a0-d45214418ab62026-05-25Warnings, Adverse reactionsName fallback
generic name: ETHOSUXIMIDE
ETHOSUXIMIDEETHOSUXIMIDEPAI Holdings, LLC dba PAI Pharma8a5cc930-0b36-48a8-9ad0-de633b2087422025-10-17Warnings, Adverse reactionsName fallback
brand name: ETHOSUXIMIDE
generic name: ETHOSUXIMIDE
EthosuximideETHOSUXIMIDEEpic Pharma, LLCa040dab2-0d70-4c02-a830-5ba1e3506a1b2025-01-08Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
EthosuximideETHOSUXIMIDEEpic Pharma, LLC85c50760-98cc-4888-b27f-146937acc8932025-01-07Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
ETHOSUXIMIDEETHOSUXIMIDEChartwell RX, LLC43fdfd16-c723-452a-9c1d-accf6f7c622e2024-10-09Warnings, Adverse reactionsName fallback
brand name: ETHOSUXIMIDE
generic name: ETHOSUXIMIDE
EthosuximideETHOSUXIMIDEBryant Ranch Prepack867b54c4-4ce4-4c00-a03b-f108f1000e292024-04-03Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
EthosuximideETHOSUXIMIDEBionpharma Inc.efb047e8-0020-4504-97fa-6aa1af3af05e2023-12-27Warnings, Adverse reactionsName fallback
brand name: Ethosuximide
generic name: ETHOSUXIMIDE
ZarontinETHOSUXIMIDEParke-Davis Div of Pfizer Inc7bf3e616-45e8-4469-a75d-4d824ce951ea2023-07-13Warnings, Adverse reactionsName fallback
generic name: ETHOSUXIMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-9660EthosuximideEthosuximideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-9660EthosuximideEthosuximideTeva Pharmaceuticals USA, Inc.ANDACurrent