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 42.

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
2026-08-18 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
2026-08-18 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 1 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.a1b28234-1f7c-40bf-80a7-6cc98b3839fe2026-08-05Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMMicro Labs Limited1e3cfafe-5784-4ec6-91dc-cd74b01d0bb42026-08-03Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
Levetiracetam LevetiracetamLEVETIRACETAMAtlantic Biologicals Corp.56fed03f-38c3-4273-8fd7-522bc508bf362026-07-27Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCa91defd2-486b-4995-ba4c-640525ab575d2026-07-21Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.dfc218c5-672a-420a-b59e-2e0b054e99ad2026-07-14Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.ae405796-1eca-4890-bcb2-e1b07654a24d2026-07-08Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMBryant Ranch Prepackace53552-d616-45e8-9f99-2f0041d0b4302026-07-06Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCoupler LLC266d4ead-fda2-f030-e063-6394a90a68e22026-07-06Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.1c26c0ad-9d37-45c5-9091-849509f4fc012026-07-02Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMBryant Ranch Prepack90e01877-abcb-4697-a7ed-9afe5ee770502026-06-29Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMUnit Dose Solutions, Inc.551626eb-3282-e439-e063-6294a90a83142026-06-25Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMDirect_Rx5517b148-1eff-6421-e063-6394a90a94982026-06-25Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMBryant Ranch Prepackbb6e1c75-66eb-4d18-af70-9b51fb67c4d62026-06-24Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.a05bbfa4-c34f-4134-8207-db79e4c704452026-06-12Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.23073db5-3fc4-4051-a22d-e49a63e426472026-06-10Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.94d042f7-93b9-43bd-9ace-cfc61903b4d72026-06-08Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.74ccc9f1-b957-4b1b-9464-1b5e3318c9162026-06-08Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c4b2da6a-ed50-4a54-90bd-32f76b1787362026-06-08Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCoupler LLC53843871-23e3-974e-e063-6394a90a80422026-06-05Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCf924d55d-d7ec-4448-b54e-3a7eaf5a1cab2026-06-04Warnings, Adverse reactionsName fallback
generic name: LEVETIRACETAM