FDA.reportPublic FDA data

Application 213957

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5728Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
70710-1161Meclizine HydrochlorideMeclizine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1162Meclizine HydrochlorideMeclizine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1539Meclizine HydrochlorideMeclizine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1540Meclizine HydrochlorideMeclizine HydrochlorideCadila Healthcare LimitedANDACurrent