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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LacosamideLACOSAMIDEIndoco Remedies Limitedba337b2c-7c1f-4f7b-ba93-054f502400f32024-03-26Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAlembic Pharmaceuticals Inc.07b7b3f2-16a0-4deb-883b-10522676d9662023-11-09Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEZydus Lifesciences Limited3bc84c70-bc1d-4a72-bbe7-86f32cd646d02023-10-03Name fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
LacosamideLACOSAMIDETris Pharma Inc7f37f8b8-07d3-48c4-a0c4-7652b62a1ad92023-06-26Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEAlembic Pharmaceuticals Limited46b98d5e-fdb6-483a-b022-8b1f0aa832c52023-01-27Warnings, Adverse reactionsName fallback
brand name: Lacosamide
generic name: LACOSAMIDE
LACOSAMIDELACOSAMIDEXLCare Pharmaceuticals Inc.c7793da3-787b-4364-9192-7caab49066f12023-01-27Warnings, Adverse reactionsName fallback
brand name: LACOSAMIDE
generic name: LACOSAMIDE
lacosamideLACOSAMIDEMSN LABORATORIES PRIVATE LIMITED0ae4e2d1-305d-4045-95da-cfe7c2d8b4352022-04-21Name fallback
brand name: lacosamide
generic name: LACOSAMIDE
LacosamideLACOSAMIDEIndoco Remedies Limited145b4fae-ce6d-43e8-a474-fcb9dff92a532022-03-09Warnings, 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.