Application 040596

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1539PromethazinePromethazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8154Promethazine HydrochloridePromethazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-512Promethazine HydrochloridePromethazine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-589Promethazine HydrochloridePromethazine HydrochlorideRebel Distributors CorpANDACurrent
21695-885Promethazine HydrochloridePromethazine HydrochlorideRebel Distributors CorpANDACurrent
50090-4811Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4811Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4812Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4812Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4813Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4813Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4875Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4875Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
51655-112Promethazine HydrochloridePromethazine HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-114Promethazine hydrochloridePromethazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-588Promethazine hydrochloridePromethazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
52959-534Promethazine HydrochloridePromethazine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53002-4021Promethazine HydrochloridePromethazine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53808-0545Promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
55154-4775Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
60687-660Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
60760-456Promethazine HydrochloridePromethazine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-456Promethazine HydrochloridePromethazine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
63629-1591Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1591Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1591Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8187Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
64725-0041Promethazine HydrochloridePromethazine HydrochlorideTYA PharmaceuticalsANDACurrent
65841-040Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-040Promethazine HydrochloridePromethazine HydrochlorideZydus Lifesciences LimitedANDACurrent
65841-040Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-040Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-041Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-041Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-041Promethazine HydrochloridePromethazine HydrochlorideZydus Lifesciences LimitedANDACurrent
65841-041Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-042Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-042Promethazine HydrochloridePromethazine HydrochlorideZydus Lifesciences LimitedANDACurrent
65841-042Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
65841-042Promethazine HydrochloridePromethazine HydrochlorideCadila Healthcare LimitedANDACurrent
67296-0198Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0198Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68001-161Promethazine HydrochloridePromethazine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-161Promethazine HydrochloridePromethazine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-162Promethazine HydrochloridePromethazine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-162Promethazine HydrochloridePromethazine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-163Promethazine HydrochloridePromethazine HydrochlorideBluePoint LaboratoriesANDACurrent
68001-163Promethazine HydrochloridePromethazine HydrochlorideBluePoint LaboratoriesANDACurrent
68071-4809Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4809Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4809Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4865Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4865Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4865Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-154Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
68084-154Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
68084-154Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
68084-155Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
68084-155Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
68084-155Promethazine HydrochloridePromethazine HydrochlorideAmerican Health PackagingANDACurrent
68382-040Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-040Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-040Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-041Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-041Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-041Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-042Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-042Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-042Promethazine HydrochloridePromethazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7886Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7886Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1306Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1306Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1306Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1306Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1306Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1306Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2488Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2488Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2488Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent