FDA.reportPublic FDA data

Application 088864

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE W/ DEXTROMETHORPHANDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL15MG/5ML;6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0604Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0604Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine HydrochlorideAtlantic Biologicals CorpsANDACurrent
21695-698Promethazine Hydrochloride and Dextromethorphan HydrobromidePromethazine Hydrochloride and Dextromethorphan HydrobromideRebel Distributors CorpANDACurrent
50090-4934Promethazine Hydrochloride and Dextromethorphan Hydrobromidepromethazine hydrochloride and dextromethorphan hydrobromideA-S Medication SolutionsANDACurrent
60432-604Promethazine Hydrochloride and Dextromethorphan Hydrobromidepromethazine hydrochloride and dextromethorphan hydrobromideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-604Promethazine Hydrochloride and Dextromethorphan Hydrobromidepromethazine hydrochloride and dextromethorphan hydrobromideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-604Promethazine Hydrochloride and Dextromethorphan Hydrobromidepromethazine hydrochloride and dextromethorphan hydrobromideMorton Grove Pharmaceuticals, Inc.ANDACurrent
63187-355Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine HydrochlorideProficient Rx LPANDACurrent