FDA.reportPublic FDA data

Application 087127

Type
ANDA
Sponsor
AUREX

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1553Meclizine Hydrochloridemeclizine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-383Meclizine HydrochlorideMeclizine HydrochlorideRebel Distributors Corp.ANDACurrent
49884-034Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-034Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
52959-225Meclizine Hydrochloridemeclizine hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
60429-204Meclizine Hydrochloridemeclizine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent