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 3 of 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.7ad18b68-ba16-4810-9c3e-27fa970454e82026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limited03610cdf-7eaa-445c-a441-ff17be5a7c682026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINERising Pharma Holdings, Inc.f54690b3-bcbb-4d94-95b9-b7591af001172026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.260dc37d-6e64-4688-82dc-10a1a428af172026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAurobindo Pharma Limitede08920c2-04a3-4fb5-acc5-0af3140f82e92026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINETorrent Pharmaceuticals Limited52df02a7-83da-4b20-9951-69790237dc242026-03-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.df34faa4-829e-413a-a230-cbec604eead92026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAmerican Health Packaging6034a8b8-9e80-43ca-b84f-ea82f788268c2026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
lamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.05cba628-b12c-44d8-89a8-3522fe417cc12026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.4bd7193f-a81a-4909-90c2-7f324fc6ddfd2026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEGlenmark Pharmaceuticals Inc., USA50fcf452-2d21-493e-a1dd-0c6ea9ac61842026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
Lamotrigine Extended-ReleaseLAMOTRIGINEPar Health USA, LLCd5ec4d58-c669-4ab4-ba62-b710075368542026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.634dbe6c-4874-4d54-aa25-be02d3341f162026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAvKAREa63e19c0-a093-e896-e053-2a95a90a7ccd2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENuCare Pharmaceuticals, Inc.47fd2592-2fc6-9787-e063-6394a90a8f012026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEQuallent Pharmaceuticals Health LLC7977c87f-b459-486a-9edc-0a2071c46f4c2026-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENorthwind Health Company, LLC03fd8413-df56-50ab-e063-6394a90a69502026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENorthwind Health Company, LLCdb5f7ee5-9bd9-1819-e053-2a95a90a91df2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINENorthwind Health Company, LLCf7587283-781b-e111-e053-6394a90ad4cc2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENorthstar Rx LLC.aabc64fe-1f17-4140-81f2-7d4506db6c8b2025-12-31Boxed 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