FDA.reportPublic FDA data

Application 083426

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5307Promethazine HydrochloridePromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5307Promethazine HydrochloridePromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
10544-618Promethazine HydrochloridePromethazine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-453Promethazine hydrochloridePromethazine hydrochlorideRebel Distributors CorpANDACurrent
49999-090Promethazine HydrochloridePromethazine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1902Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1904Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4603Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
58118-5307Promethazine HydrochloridePromethazine HydrochlorideClinical Solutions WholesaleANDACurrent
58118-5307Promethazine HydrochloridePromethazine HydrochlorideClinical Solutions WholesaleANDACurrent
58118-5307Promethazine HydrochloridePromethazine HydrochlorideClinical Solutions WholesaleANDACurrent
61919-191PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-191PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-191PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-191PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-191PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
63187-829Promethazine HydrochloridePromethazine HydrochlorideProficient Rx LPANDACurrent
63187-829Promethazine HydrochloridePromethazine HydrochlorideProficient Rx LPANDACurrent
63629-1742Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1742Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1742Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6327Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6327Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
64725-5307Promethazine HydrochloridePromethazine HydrochlorideTYA PharmaceuticalsANDACurrent
67296-0086Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0086Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0086Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-4514Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4514Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4514Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,InANDACurrent
68071-4544Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4544Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7287Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-2481Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2481Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2481Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2481Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-139Promethazine HydrochloridePromethazine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-139Promethazine HydrochloridePromethazine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent