FDA.reportPublic FDA data

Application 208784

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3008LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3009LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
55154-4848LansoprazoleLansoprazoleCardinal HealthANDACurrent
55154-4848LansoprazoleLansoprazoleCardinal Health 107, LLCANDACurrent