FDA.reportPublic FDA data

Application 087128

Type
ANDA
Sponsor
AUREX

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-1736Meclizine Hydrochloridemeclizine hydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0615-1554Meclizine Hydrochloridemeclizine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-108Meclizine Hydrochloridemeclizine hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-237Meclizine HydrochlorideMeclizine HydrochlorideRebel Distributors Corp.ANDACurrent
49884-035Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-035Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
50436-3988Meclizine Hydrochloridemeclizine hydrochlorideUnit Dose ServicesANDACurrent
51655-134MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
53808-0380Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
60429-205Meclizine Hydrochloridemeclizine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent