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 8 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLC57f09129-7151-4a75-9d73-9dd32f74ba432024-03-27Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLCdd713e60-478c-43cd-b680-ff594a0b38642024-03-27Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMPAI Holdings, LLC dba PAI Pharma9dca1330-52ca-47a4-a134-ec55c9d5786d2024-03-27Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
ELEPSIA XR 1000 MGLEVETIRACETAMTRIPOINT THERAPEUTICS, LLCcac83d47-88a2-4447-a0c0-90b44ffda0ac2024-03-25Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMGland Pharma Limitedaa883d9c-c6cd-44ab-a1de-058985e4f97f2024-03-25Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMMylan Institutional LLC70e52e89-3844-4cd9-a406-b29e9520a12c2024-03-15Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMProficient Rx LP6bdbc193-d86b-4bd5-8e88-4ea964d2cdde2024-03-01Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMPatrin Pharma, Inc.49117cee-a96c-4593-91a7-8a133e3f09392024-02-15Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
levetiracetamLEVETIRACETAMMAJOR PHARMACEUTICALS6913c611-4994-4501-8ed9-45161f90373e2023-12-28Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMWG Critical Care, LLC5e5b0ed3-b104-45a7-bb3e-ee56febb46e82023-10-30Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMNatco Pharma USA LLC34af3602-0188-4d2e-904b-2e40000bb45c2023-08-05Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMArmas Pharmaceuticals Inc.7be45c40-8d75-4c40-97a4-95067129bc2a2023-07-24Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
Levetiracetam ERLEVETIRACETAMProficient Rx LPa0ad8200-70c9-4f4f-86c5-4a8c6c9f02232022-12-01Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
Levetiracetam ERLEVETIRACETAMProficient Rx LP57b9dccb-6ee6-4e89-ab26-4c478e2df2b52022-04-01Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCcc4a06f1-6509-4650-b20c-259a393537332022-02-28Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCcc41696c-9cf0-4410-bacc-09132ee805ce2022-01-24Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMPrinston Pharmaceutical Inc.d818ef84-9b3e-434b-92d9-910cfa8af7da2020-08-01Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMDr. Reddy's Laboratories Limited1f3c04d9-cccb-06a3-a0f3-f7c9228ee7432018-12-05Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMDr. Reddy's Laboratories Limitedee03507b-cb35-4fe9-ae7b-85ea89f876f02018-12-05Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMExelan Pharmaceuticals, Inc.28c0e61e-1af9-410a-9fa9-b71bf99a776b2018-11-29Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM

Reported adverse events (FAERS/openFDA)#

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