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 4 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMAdvanced Rx of Tennessee, LLC45a03a43-04db-9138-e063-6394a90a12fa2025-12-10Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMGranules Pharmaceuticals Inc.b4781ec4-43ad-4052-9a6a-b24fda119b322025-12-04Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMGuardian Drug Companye77162ff-0ff9-45ca-95fc-da6ea24ce5a22025-12-02Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
Levetiracetam Extended-ReleaseLEVETIRACETAMGolden State Medical Supply, Inc.5dde1889-a217-4493-9a71-9fd39ed046302025-11-24Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutions6e31e766-6504-4f20-8831-1953363cace02025-11-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMHp Halden Pharma AS1d9abcce-8ef7-422b-bf4b-5835bf4dbb342025-11-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMHp Halden Pharma AS6951de41-4a16-4cca-8039-44fc814070812025-11-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMHp Halden Pharma AS35bb1e5f-d5cd-4e7f-a056-48c0cf9ebd762025-11-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutions01aef7f7-6092-4e39-8451-dc02d8db92542025-11-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMBaxter Healthcare Corporation8e381590-1147-46f3-9cbd-dc97160134442025-11-20Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutions58ed7049-44c6-4f97-9174-c0e1504586a62025-11-19Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutions5eb7bea5-c95f-4a38-a5bb-c20d1549c7972025-11-19Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutionsbc12f0b0-e05c-48e4-ad08-0ff14a818a642025-11-19Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCoupler LLC43df4156-0958-e496-e063-6294a90a53292025-11-18Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMA-S Medication Solutionsb9597cd5-5745-494a-bd72-93071ed221da2025-11-18Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMMylan Institutional Inc.08e1bfea-7f3f-42d9-823d-f75080e664ff2025-11-12Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAM solutionLEVETIRACETAMChartwell Governmental & Specialty RX, LLC.e1ebd960-79a4-4632-b727-4e98118241132025-11-11Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMEugia US LLC3e43c17f-7e7e-4ccd-b321-1dd5e62cdafd2025-11-11Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMTAGI Pharma, Inc.72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c2025-11-04Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMLupin Pharmaceuticals, Inc.18648f51-a37c-41e1-b451-123bc0cf54462025-10-30Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM

Reported adverse events (FAERS/openFDA)#

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