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 2 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lacosamide Oral SolutionLACOSAMIDEChartwell Governmental & Specialty RX, LLC.e265fd09-8149-4423-a317-5760d34b8e9b2026-02-25Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
LacosamideLACOSAMIDEKanchan Healthcare Inc41f02424-231d-4039-a122-df4b49dc99982026-01-29Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEAnthea Pharma Private Limitedb4f2620a-2047-4b33-bb75-18702f6c55e62026-01-24Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEGLENMARK PHARMACEUTICALS INC., USAbc7ed8a6-acce-48f2-9ef1-4e366c71dbbc2026-01-24Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEVirtus Pharmaceuticals, LLC01162e2f-967b-4596-8188-c0d9889c38142026-01-23Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LacosamideLACOSAMIDESintetica US LLC08ac486a-4f61-4e9e-9683-d1a66a6c2a4d2026-01-04Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
Lacosamide Oral SolutionLACOSAMIDEAjenat Pharmaceuticals LLCcb29da34-89aa-405a-8fbc-2308bda371872025-12-29Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
lacosamideLACOSAMIDEGlenmark Pharmaceuticals Inc. USAdf1d2e6a-6129-49c9-b2c1-0fdf73f38b9c2025-12-17Warnings, Adverse reactionsName fallback
brand name: lacosamide
generic name: LACOSAMIDE
Lacosamide Oral SolutionLACOSAMIDEKesin Pharma Corporation446f14be-5d79-26b9-e063-6294a90ae0b52025-11-25Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEScieGen Pharmaceuticals Incf4ffa3ad-1278-4772-9ef8-ed6fdaa476052025-10-31Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LacosamideLACOSAMIDEKanchan Healthcare Inc5c03b90e-6985-4005-b6c5-44626d0600d72025-10-19Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDENorthStar RxLLC9dffda6c-9e44-478f-9e02-9da3ab4c50e12025-10-05Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDECamber Pharmaceuticals, Inc.bbd80370-3d23-41f8-8914-c6ea897c01542025-09-29Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAscend Laboratories, LLC9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de2025-08-11Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
Lacosamide Oral SolutionLACOSAMIDEKesin Pharmaceutical Corporation3ba29442-4e8a-c2b2-e063-6294a90a1bbf2025-08-05Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
LacosamideLACOSAMIDEWestminster Pharmaceuticals, LLC61e3747a-3957-4840-81f0-313aefbd5d2b2025-07-29Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
MOTPOLY XRLACOSAMIDEAucta Pharmaceuticals, Inc.fb8235b4-4cd3-6f22-e053-6294a90a545c2025-07-16Warnings, Adverse reactionsName fallback
generic name: LACOSAMIDE
LacosamideLACOSAMIDEANI Pharmaceuticals, Inc.68033c90-d9cc-4d5f-896c-9a61a0c3b5292025-06-25Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAdvanced Rx of Tennessee, LLC325df1b7-4908-0c03-e063-6294a90ad8442025-04-09Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEPrecision Dose, Inc.fe24b28b-ca15-4dfd-a198-53cdc2c8cb992025-03-31Warnings, 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.