FDA.reportPublic FDA data

Application 220366

Type
ANDA
Sponsor
STERANCO HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACOSAMIDELACOSAMIDESOLUTION;ORAL10MG/MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220366-001LACOSAMIDELACOSAMIDE10MG/MLSOLUTION / ORAL2026-05-21

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 22:38:342026-08A220366-001LACOSAMIDE10MG/MLSOLUTION / ORAL2026-05-2184e616aacf4f…
2026-08-18 06:07:402026-07A220366-001LACOSAMIDE10MG/MLSOLUTION / ORAL2026-05-21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220366-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2026-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220366-001AA1a50c72e98297…

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 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lacosamide Oral SolutionLACOSAMIDEAvKARE5b10986e-0809-b6d1-e063-6394a90a57382026-09-09Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
LacosamideLACOSAMIDENovadoz Pharmaceuticals LLCb9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b2026-08-12Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEWestminster Pharmaceuticals, LLCecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb862026-08-11Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEGlenmark Pharmaceuticals Limited458e80da-8fc1-4715-9b4b-bc4f388f933f2026-08-11Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEREMEDYREPACK INC.edd20b60-6265-4c4e-a95a-aaf8103cd8522026-07-21Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEFosun Pharma USAec1c5ddb-1143-7e6a-e053-2995a90a83822026-07-21Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEGland Pharma Limited779d2381-f590-45f9-a191-f44af821f4c82026-07-14Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAurobindo Pharma Limited6140b3f1-ff60-427c-91d7-15af99fd78f12026-06-29Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAurobindo Pharma Limited614490ce-a62c-4222-8e4b-ce802cf630282026-06-22Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.c5b91128-f838-4e98-9684-5f477fc7af062026-06-22Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEZydus Pharmaceuticals USA Inc.16a9afd2-35a6-44a9-b1d9-ca195c8640d72026-06-11Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LacosamideLACOSAMIDEMajor Pharmaceuticalsc83d2156-4dde-4316-98f1-b3dc751f3eac2026-06-09Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDENorthStar Rx LLC48fcaa27-baaa-446e-a282-0c3e232cd1512026-05-28Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEDr. Reddy's Laboratories Inc.cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b42026-05-21Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
VimpatLACOSAMIDEUCB, Inc.9e79b42c-38a3-4b2c-a196-a5a1948250e22026-05-12Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEZydus Pharmaceuticals USA Inc.07356cf2-224b-40d2-b827-e10a6b42c2322026-05-07Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LacosamideLACOSAMIDEBryant Ranch Prepack024bca92-cac5-4832-a1ff-c1b3d5994ba02026-05-06Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.e24d3c45-a559-4fca-a7be-74ce37a7066e2026-04-14Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEClinical Solutions Wholesale, LLC264c3718-67ea-4483-b036-2514c853635a2026-03-24Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAmerican Health Packaging19060029-c158-4a37-9261-cfe3b2b5b1e32026-03-06Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE

Reported adverse events (FAERS/openFDA)#

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