FDA.reportPublic FDA data

Application 040649

Type
ANDA
Sponsor
SLATE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE DMDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL15MG/5ML;6.25MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-1586PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochloridePar PharmaceuticalANDACurrent
0603-1586PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochloridePar PharmaceuticalANDACurrent
17856-1586PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
33261-732PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
50090-0225PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0225PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4125PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideA-S Medication SolutionsANDACurrent
50436-1867PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideUnit Dose ServicesANDACurrent
53002-4260PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4260PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4262Promethazine Hydrochloride and Dextromethorphan Hydrobromide OralPromethazine Hydrochloride and Dextromethorphan Hydrobromide OralRPK Pharmaceuticals, Inc.ANDACurrent
63187-272PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideProficient Rx LPANDACurrent
63187-272PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideProficient Rx LPANDACurrent
68071-1643PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1643PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8100Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPreferred Pharmaceuticals Inc.ANDACurrent
68788-8100Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPreferred Pharmaceuticals Inc.ANDACurrent
68788-9097PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70436-155Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionSlate Run Pharmaceuticals, LLCANDACurrent
70436-155Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionSlate Run Pharmaceuticals, LLCANDACurrent
70518-0418PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
71205-654Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPromethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionProficient Rx LPANDACurrent