FDA.reportPublic FDA data

Application 090287

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZTROPINE MESYLATEBENZTROPINE MESYLATEINJECTABLE;INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9729Benztropine MesylateBenztropine MesylateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9729Benztropine MesylateBenztropine MesylateHikma Pharmaceuticals USA Inc.ANDACurrent