FDA.reportPublic FDA data

Application 073283

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEMASTINE FUMARATECLEMASTINE FUMARATETABLET;ORAL2.68MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0308Clemastine FumarateClemastine FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0308Clemastine FumarateClemastine FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0308Clemastine FumarateClemastine FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0308Clemastine FumarateClemastine FumarateTeva Pharmaceuticals USA, Inc.ANDACurrent
51655-425Clemastine FumarateClemastine FumarateNorthwind Pharmaceuticals, LLCANDACurrent