FDA.reportPublic FDA data

Application 040659

Type
ANDA
Sponsor
JUBILANT CADISTA

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
10544-081MECLIZINE HYDROCHLORIDEMeclizine HydroclorideBlenheim Pharmacal, Inc.ANDACurrent
33261-718MECLIZINE HYDROCHLORIDEMeclizine HydroclorideAidarex Pharmaceuticals LLCANDACurrent
35356-901MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-901MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-901MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-901MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-914MECLIZINE HYDROCHLORIDEMeclizine HydroclorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-102Meclizine HydroclorideMeclizine HydroclorideQPharma IncANDACurrent
42708-102Meclizine HydroclorideMeclizine HydroclorideQPharma IncANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, InANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-899MECLIZINE HYDROCHLORIDEMeclizine HydrocloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
49467-124NAUS-EASEMECLIZINE HYDROCHLORIDESunascen Therapeutics LLCANDACurrent
50090-2893MECLIZINE HYDROCHLORIDEMeclizine HydroclorideA-S Medication SolutionsANDACurrent
50090-2893Meclizine HydroclorideMeclizine HydroclorideA-S Medication SolutionsANDACurrent
50090-4577MECLIZINE HYDROCHLORIDEMeclizine HydroclorideA-S Medication SolutionsANDACurrent
50090-5203MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50436-3986MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideUnit Dose ServicesANDACurrent
51655-107MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
51655-107Meclizine HydrochlorideMeclizine HydrochlorideNorthwind Pharmaceuticals, LLCANDACurrent
52959-033MECLIZINE HYDROCHLORIDEMeclizine HydroclorideH.J. Harkins Company, Inc.ANDACurrent
53002-3510MECLIZINE HYDROCHLORIDEMeclizine HydroclorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3510MECLIZINE HYDROCHLORIDEMeclizine HydroclorideRPK Pharmaceuticals, Inc.ANDACurrent
53808-1116MECLIZINE HYDROCHLORIDEMeclizine HydroclorideDOH CENTRAL PHARMACYANDACurrent
59746-121MECLIZINE HYDROCHLORIDEMeclizine HydroclorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-121MECLIZINE HYDROCHLORIDEMeclizine HydroclorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-121MECLIZINE HYDROCHLORIDEMeclizine HydroclorideJUBILANT CADISTA PHARMACEANDACurrent
59746-122MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideJUBILANT CADISTA PHARMACEANDACurrent
59746-122MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-122MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
60760-087MECLIZINE HYDROCHLORIDEMeclizine HydroclorideSt. Mary's Medical Park PharmacyANDACurrent
60760-087MECLIZINE HYDROCHLORIDEMeclizine HydroclorideSt. Mary's Medical Park PharmacyANDACurrent
60760-087MECLIZINE HYDROCHLORIDEMeclizine HydroclorideSt. Mary's Medical Park PharmacyANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDIRECT RXANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDIRECT RXANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDIRECT RXANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDirect_RxANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDirect_RxANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDIRECT RXANDACurrent
61919-146Meclizine HydrochlorideMeclizine HydrochlorideDirect_RxANDACurrent
61919-886MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-886MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirect_RxANDACurrent
63187-996MECLIZINE HYDROCHLORIDEMeclizine HydroclorideProficient Rx LPANDACurrent
63187-996MECLIZINE HYDROCHLORIDEMeclizine HydroclorideProficient Rx LPANDACurrent
63187-996MECLIZINE HYDROCHLORIDEMeclizine HydroclorideProficient Rx LPANDACurrent
63187-996MECLIZINE HYDROCHLORIDEMeclizine HydroclorideProficient Rx LPANDACurrent
63629-2432MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2432MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7965MECLIZINE HYDROCHLORIDEMeclizine HydroclorideBryant Ranch PrepackANDACurrent
63629-7965MECLIZINE HYDROCHLORIDEMeclizine HydroclorideBryant Ranch PrepackANDACurrent
63629-8092MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideBryant Ranch PrepackANDACurrent
67296-1041MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-1041MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-1041MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
68071-3017MECLIZINE HYDROCHLORIDEMeclizine HydroclorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3017MECLIZINE HYDROCHLORIDEMeclizine HydroclorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3308MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideNuCare Pharmaceuticals,InANDACurrent
68071-3308MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3308MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4488MECLIZINE HYDROCHLORIDEMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4694MECLIZINE HYDROCHLORIDEMeclizine HydroclorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4694MECLIZINE HYDROCHLORIDEMeclizine HydroclorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4694MECLIZINE HYDROCHLORIDEMeclizine HydroclorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4694MECLIZINE HYDROCHLORIDEMeclizine HydroclorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0447MECLIZINE HYDROCHLORIDEMeclizine HydroclorideREMEDYREPACK INC.ANDACurrent
70518-1308MECLIZINE HYDROCHLORIDEMeclizine HydroclorideREMEDYREPACK INC.ANDACurrent
70518-1308MECLIZINE HYDROCHLORIDEMeclizine HydroclorideREMEDYREPACK INC.ANDACurrent
70518-1308MECLIZINE HYDROCHLORIDEMeclizine HydroclorideREMEDYREPACK INC.ANDACurrent
70518-1308MECLIZINE HYDROCHLORIDEMeclizine HydroclorideREMEDYREPACK INC.ANDACurrent
70934-238MECLIZINE HYDROCHLORIDEMeclizine HydroclorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent