FDA.reportPublic FDA data

Application 073399

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEMASTINE FUMARATECLEMASTINE FUMARATESYRUP;ORALEQ 0.5MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73308-358Clemastine FumarateClemastine FumarateAyurax, LLCANDACurrent
73308-358Clemastine FumarateClemastine FumarateAyurax, LLCANDACurrent
73308-358Clemastine FumarateClemastine FumarateAyurax, LLCANDACurrent
73308-358Clemastine FumarateClemastine FumarateAyurax, LLCANDACurrent