FDA.reportPublic FDA data

Application 022509

Type
NDA
Sponsor
SMITHKLINE BEECHAM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL25MGNoNo
002LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL50MGNoNo
003LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL100MGNoNo
004LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEA-S Medication Solutions84277e2c-370c-4510-92bc-ef33a4a0f5082025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC9e5c2d76-47a6-4a57-b23c-2398b307380c2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAjanta Pharma USA Inc.9dfb5f87-0150-4c26-a89f-34f1ab3895002025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limiteda69542ea-5b6f-15c1-9e7a-90ac839971d32025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENorthStar Rx LLC9ab07d6b-ae4a-a310-5572-b266676cd29e2025-11-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAdvagen Pharma Limited4ca9d713-ab63-48bf-9386-29301a842e602025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.e849033b-a3bc-408e-88de-7cd1d26609492025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.eb436371-d188-4803-a864-07b90c357e572025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LAMICTALLAMOTRIGINEGlaxoSmithKline LLCd7e3572d-56fe-4727-2bb4-013ccca226782025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LAMICTAL XRLAMOTRIGINEGlaxoSmithKline LLC3e2c9a35-6a39-41d7-ad84-3c0bb8894b092025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMICTAL XR
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEZydus Lifesciences Limited0f2f7421-56d4-45d0-9d2d-dc1edaede0392025-10-04Name fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack8e1e4fa8-881c-4618-88f6-018ab15db44d2025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c2025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack53774022-ea0c-42a9-a720-dc755c77b8512025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINECoupler LLC3dfdcc2d-b7c5-7abf-e063-6394a90a24a62025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepackd33c4293-347c-49a1-9d98-f291c3dab6da2025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEJubilant Cadista Pharmacuticals Inc.0b0f0209-edbd-46f3-9bed-762cbea0d7372025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack2cf33586-e48a-4b4e-b14b-33de2be63c1d2025-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack4bbc140c-6092-416d-865d-49b89c5ecdd02025-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepackcf03f130-067f-401c-8501-0d78a989a3192025-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60206ORIG2019-10-02
44764ORIG2011-02-17
22040ORIG2010-12-01
29794ORIG2010-02-17
38775ORIG2010-02-16
53309ORIG1900-01-01
53308ORIG1900-01-01