FDA.reportPublic FDA data

Application 202640

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5485Meclizine HydrochlorideMeclizineMylan Pharmaceuticals Inc.ANDACurrent
0378-5486Meclizine HydrochlorideMeclizineMylan Pharmaceuticals Inc.ANDACurrent
43063-662Meclizine HydrochlorideMeclizinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-662Meclizine HydrochlorideMeclizinePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2048Meclizine HydrochlorideMeclizineA-S Medication SolutionsANDACurrent
51079-423Meclizine HydrochlorideMeclizineMylan Institutional Inc.ANDACurrent
51079-511Meclizine HydrochlorideMeclizineMylan Institutional Inc.ANDACurrent