FDA.reportPublic FDA data

Application 218364

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/100ML (5MG/ML)NoNo
002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1GM/100ML (10MG/ML)NoNo
003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1.5GM/100ML (15MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218364-001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08
A218364-002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08
A218364-003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A218364-001AP
A218364-002AP
A218364-003AP

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 22:38:342026-08A218364-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-0884e616aacf4f…
2026-09-14 22:38:342026-08A218364-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-0884e616aacf4f…
2026-09-14 22:38:342026-08A218364-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-0884e616aacf4f…
2026-08-18 06:07:402026-07A218364-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A218364-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A218364-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218364-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218364-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218364-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2026-05-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218364-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A218364-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A218364-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A218364-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A218364-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A218364-003AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218364-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218364-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218364-003AP1a50c72e98297…

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 6 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals Inc.8c16bc7b-672c-420a-a457-3500605333752025-03-20Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutionsc82313cb-744f-45ef-b74c-1bdd055b21932025-03-18Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMKesin Pharma Corporation30a4626d-74f3-6385-e063-6394a90a29502025-03-01Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c2177034-e164-453c-be02-1cf91ce27a072025-02-28Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMAmerican Health Packaging3be7c30b-f35d-4dde-8bf8-24f67bd708652025-02-18Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCoupler LLC2d596153-c49b-273f-e063-6294a90ac6632025-02-04Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMTorrent Pharmaceuticals Limited6ab24168-058d-496e-9023-da8ee6353eb32025-01-22Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMNCS HealthCare of KY, LLC dba Vangard Labsdfb7c640-623e-43d1-8ee8-479dccd53d0a2025-01-16Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMNovadoz Pharmaceuticals LLC1c4450a1-6c05-4b45-a733-c19b4e8619702024-12-31Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMBluePoint Laboratories8b74b8bc-d95c-4471-8f74-c3117243bf892024-12-11Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMAmerican Health Packagingfc8bf57e-8aa2-4d3c-856d-b19de65e3ba02024-11-18Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutions8a8472dc-b97e-445d-bf51-b6e618cae1b62024-10-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMNorthStar Rx LLC483a42b9-c8f3-4f8b-98be-fcac5ab23c7c2024-10-14Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMAurobindo Pharma Limitedf65ec19d-b90e-452e-b761-c68b1cf2c8922024-09-12Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMXLCare Pharmaceuticals Inc.567f09e6-ccd5-4688-a22b-0bc66a5fe31e2024-09-06Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
levetiracetamLEVETIRACETAMNovadoz Pharmaceuticals LLC1ec4c05d-7fba-4c02-a3bf-4343a8a421d52024-08-28Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMBryant Ranch Prepackb738377c-035e-4b2e-9909-0a8fe07aa0fb2024-08-12Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMScieGen Pharmaceuticals, Inc.1d71212b-ac97-4a61-8192-8e83035400192024-08-01Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMMajor Pharmaceuticals423d2185-0931-4414-8864-7594000809ee2024-07-31Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
Levetiracetam Extended-ReleaseLEVETIRACETAMScieGen Pharmaceuticals, Inc3e32f341-9926-47a3-a942-d8b9bfa7a55b2024-07-12Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM

Reported adverse events (FAERS/openFDA)#

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