FDA.reportPublic FDA data

Application 200294

Type
ANDA
Sponsor
EPIC PHARMA LLC

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
0615-8052Meclizine HydrochlorideMeclizine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8052Meclizine HydrochlorideMeclizine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-424Meclizine HydrochlorideMeclizine HydrochlorideApotheca Inc.ANDACurrent
42806-012Meclizine HydrochlorideMeclizine HydrochlorideEpic Pharma, LLCANDACurrent
42806-012Meclizine HydrochlorideMeclizine HydrochlorideEpic Pharma LLCANDACurrent
42806-012Meclizine HydrochlorideMeclizine HydrochlorideEpic Pharma, LLCANDACurrent
42806-014Meclizine HydrochlorideMeclizine HydrochlorideEpic Pharma, LLCANDACurrent
42806-014Meclizine HydrochlorideMeclizine HydrochlorideEpic Pharma LLCANDACurrent
42806-014Meclizine HydrochlorideMeclizine HydrochlorideEpic Pharma, LLCANDACurrent
50436-0014Meclizine HydrochlorideMeclizine HydrochlorideUnit Dose ServicesANDACurrent
60760-425Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-301MECLIZINEMECLIZINEDIRECT RXANDACurrent
61919-301MECLIZINEMECLIZINEDIRECT RXANDACurrent
61919-752MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRXANDACurrent
63187-258Meclizine HydrochlorideMeclizine HydrochlorideProficient Rx LPANDACurrent
63187-258Meclizine HydrochlorideMeclizine HydrochlorideProficient Rx LPANDACurrent
66267-138Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-138Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-139Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-139Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-800Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-800Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-801Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-801Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1309Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1309Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.ANDACurrent
69677-153Meclizine HydrochlorideMeclizine HydrochlorideMAS MANAGEMENT GROUP, INC.ANDACurrent
70518-0421Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0422Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0189Meclizine HydrochlorideMeclizine HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43344ORIG2012-06-22