FDA.reportPublic FDA data

Application 200828

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL50MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL100MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1526LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1526LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1526LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1526LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-1527LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-1527LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1527LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1527LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1528LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1528LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1528LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1528LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-1529LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-1529LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1529LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1529LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9939LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9939LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9939LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9939LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9939LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9939LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-9939LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9940LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-9940LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9940LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9940LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9940LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9940LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9940LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9941LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-9942LamotrigineLAMOTRIGINEImpax GenericsANDACurrent
0115-9942LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9942LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9942LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9942LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9942LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9942LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32068ORIG2013-07-17