FDA.reportPublic FDA data

Application 201451

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGNoYes
002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL25MGNoYes
003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8224Meclizine HydrochlorideMeclizine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8224Meclizine HydrochlorideMeclizine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8303Meclizine HydrochlorideMeclizineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8303Meclizine HydrochlorideMeclizineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6516Meclizine HydrochlorideMeclizineMajor PharmaceuticalsANDACurrent
0904-6516Meclizine HydrochlorideMeclizineMajor PharmaceuticalsANDACurrent
0904-6516Meclizine HydrochlorideMeclizineMajor PharmaceuticalsANDACurrent
0904-6517Meclizine HydrochlorideMeclizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6517Meclizine HydrochlorideMeclizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6517Meclizine HydrochlorideMeclizine HydrochlorideMajor PharmaceuticalsANDACurrent
42291-609Meclizine HydrochlorideMeclizine HydrochlorideAvKAREANDACurrent
42291-609Meclizine HydrochlorideMeclizine HydrochlorideAvKAREANDACurrent
42291-609Meclizine HydrochlorideMeclizine HydrochlorideAvKARE, Inc.ANDACurrent
42708-127Meclizine HydrochlorideMeclizine HydrochlorideQPharma IncANDACurrent
42708-127Meclizine HydrochlorideMeclizine HydrochlorideQPharma IncANDACurrent
42708-127Meclizine HydrochlorideMeclizine HydrochlorideQPharma IncANDACurrent
50090-0106Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0106Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0106Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0106Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0107Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0107Meclizine HydrochlorideMeclizine HydrochlorideA-S Medication SolutionsANDACurrent
50268-522Meclizine HydrochlorideMeclizineAvPAKANDACurrent
50268-522Meclizine HydrochlorideMeclizineAvPAKANDACurrent
50268-522Meclizine HydrochlorideMeclizineAvPAKANDACurrent
50268-523Meclizine HydrochlorideMeclizine HydrochlorideAvPAKANDACurrent
50268-523Meclizine HydrochlorideMeclizine HydrochlorideAvPAKANDACurrent
50268-523Meclizine HydrochlorideMeclizine HydrochlorideAvPAKANDACurrent
53746-441Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-442Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
55700-800Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCANDACurrent
55700-800Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCANDACurrent
60760-444Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
65162-441Meclizine HydrochlorideMeclizineAmneal Pharmaceuticals LLCANDACurrent
65162-441Meclizine HydrochlorideMeclizineAmneal Pharmaceuticals LLCANDACurrent
65162-441Meclizine HydrochlorideMeclizineAmneal Pharmaceuticals LLCANDACurrent
65162-441Meclizine HydrochlorideMeclizineAmneal Pharmaceuticals LLCANDACurrent
65162-441Meclizine HydrochlorideMeclizineAmneal Pharmaceuticals LLCANDACurrent
65162-442Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-442Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-442Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-442Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-442Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-444Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-444Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-444Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-444Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-444Meclizine HydrochlorideMeclizine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
67296-1809Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1809Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1809Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-4299Meclizine HydrochlorideMeclizineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4352Meclizine HydrochlorideMeclizineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4372Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4497Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4497Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-490Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-490Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-490Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-490Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-491Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-491Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-491Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
68084-491Meclizine HydrochlorideMeclizine HydrochlorideAmerican Health PackagingANDACurrent
70518-1402Meclizine HydrochlorideMeclizineREMEDYREPACK INC.ANDACurrent
70518-1402Meclizine HydrochlorideMeclizineREMEDYREPACK INC.ANDACurrent
70518-1402Meclizine HydrochlorideMeclizineREMEDYREPACK INC.ANDACurrent
70518-1402Meclizine HydrochlorideMeclizineREMEDYREPACK INC.ANDACurrent
70518-1402Meclizine HydrochlorideMeclizineREMEDYREPACK INC.ANDACurrent
70518-2074Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2074Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2304Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2304Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2304Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2304Meclizine HydrochlorideMeclizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-138Meclizine HydrochlorideMeclizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-138Meclizine HydrochlorideMeclizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-138Meclizine HydrochlorideMeclizine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0732Meclizine HydrochlorideMeclizineBryant Ranch PrepackANDACurrent
71335-0732Meclizine HydrochlorideMeclizineBryant Ranch PrepackANDACurrent