FDA.reportPublic FDA data

Application 200143

Type
ANDA
Sponsor
BARR LABS DIV TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACAMPROSATE CALCIUMACAMPROSATE CALCIUMTABLET, DELAYED RELEASE;ORAL333MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5352Acamprosate CalciumAcamprosate CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5352Acamprosate CalciumAcamprosate CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5352Acamprosate CalciumAcamprosate CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-104Acamprosate CalciumAcamprosate CalciumAvKARE, Inc.ANDACurrent
42291-104Acamprosate CalciumAcamprosate CalciumAvKAREANDACurrent