FDA.reportPublic FDA data

Application 078042

Type
ANDA
Sponsor
ACI HEALTHCARE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET;ORAL250MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET;ORAL500MGNoNo
003LEVETIRACETAMLEVETIRACETAMTABLET;ORAL750MGNoNo
004LEVETIRACETAMLEVETIRACETAMTABLET;ORAL1GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078042-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORAL2009-01-15
A078042-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORAL2009-01-15
A078042-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORAL2009-01-15
A078042-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORAL2009-01-15

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
2026-08-01 22:54:322026-06A078042-001LEVETIRACETAM250MGTABLET / ORAL2009-01-15a50c72e98297…
2026-08-01 22:54:322026-06A078042-002LEVETIRACETAM500MGTABLET / ORAL2009-01-15a50c72e98297…
2026-08-01 22:54:322026-06A078042-003LEVETIRACETAM750MGTABLET / ORAL2009-01-15a50c72e98297…
2026-08-01 22:54:322026-06A078042-004LEVETIRACETAM1GMTABLET / ORAL2009-01-15a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.dfc218c5-672a-420a-b59e-2e0b054e99ad2026-07-14Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.ae405796-1eca-4890-bcb2-e1b07654a24d2026-07-08Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMBryant Ranch Prepackace53552-d616-45e8-9f99-2f0041d0b4302026-07-06Warnings, Adverse reactionsName fallback
brand name: LEVETIRACETAM
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCoupler LLC266d4ead-fda2-f030-e063-6394a90a68e22026-07-06Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.1c26c0ad-9d37-45c5-9091-849509f4fc012026-07-02Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMBryant Ranch Prepack90e01877-abcb-4697-a7ed-9afe5ee770502026-06-29Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMUnit Dose Solutions, Inc.551626eb-3282-e439-e063-6294a90a83142026-06-25Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMDirect_Rx5517b148-1eff-6421-e063-6394a90a94982026-06-25Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LEVETIRACETAMLEVETIRACETAMBryant Ranch Prepackbb6e1c75-66eb-4d18-af70-9b51fb67c4d62026-06-24Warnings, Adverse reactionsName fallback
brand name: LEVETIRACETAM
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.a05bbfa4-c34f-4134-8207-db79e4c704452026-06-12Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.23073db5-3fc4-4051-a22d-e49a63e426472026-06-10Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.94d042f7-93b9-43bd-9ace-cfc61903b4d72026-06-08Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.74ccc9f1-b957-4b1b-9464-1b5e3318c9162026-06-08Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c4b2da6a-ed50-4a54-90bd-32f76b1787362026-06-08Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCoupler LLC53843871-23e3-974e-e063-6394a90a80422026-06-05Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCf924d55d-d7ec-4448-b54e-3a7eaf5a1cab2026-06-04Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.c12d8af3-39a8-4690-8d47-43dec70b75792026-06-01Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM
LevetiracetamLEVETIRACETAMInjecta Medcial LLC52fa0eec-3dd9-59ca-e063-6394a90a97912026-05-29Warnings, Adverse reactionsName fallback
brand name: Levetiracetam
generic name: LEVETIRACETAM