FDA.reportPublic FDA data

Application 076388

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET;ORAL100MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET;ORAL150MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0039LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0039LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0039LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0463LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0463LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0463LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7247LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7247LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7247LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7248LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7248LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7248LamotrigineLamotrigineTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7544LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7545LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7546LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7547LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22556ORIG2012-02-14
44616ORIG2008-02-01
31115ORIG2006-09-18