FDA.reportPublic FDA data

Application 215465

Type
ANDA
Sponsor
KNACK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/5ML (100MG/ML)NoNo

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
A215465-001LEVETIRACETAMLEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUS2025-12-02

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 22:38:342026-08A215465-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUS2025-12-0284e616aacf4f…
2026-08-18 06:07:402026-07A215465-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUS2025-12-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215465-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2025-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215465-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUSAP2025-12-0231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215465-001LEVETIRACETAM500MG/5ML (100MG/ML)INJECTABLE / INTRAVENOUS2025-12-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215465-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215465-001AP131067a03dcf5…

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 9 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Inc0a9234b7-46b1-8e6c-a992-90f86cfb6e002021-12-31Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
LevetiracetamLEVETIRACETAMPrinston Pharmaceutical Inc.d818ef84-9b3e-434b-92d9-910cfa8af7da2020-08-01Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMDr. Reddy's Laboratories Limited1f3c04d9-cccb-06a3-a0f3-f7c9228ee7432018-12-05Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMDr. Reddy's Laboratories Limitedee03507b-cb35-4fe9-ae7b-85ea89f876f02018-12-05Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMExelan Pharmaceuticals, Inc.28c0e61e-1af9-410a-9fa9-b71bf99a776b2018-11-29Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMAmneal Pharmaceuticals LLCd7932a2c-a3b7-46df-a306-1f17716160a02017-11-28Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM

Reported adverse events (FAERS/openFDA)#

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