FDA.reportPublic FDA data

Application 202940

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDESYRUP;ORAL2MG/5ML;10MG/5ML;30MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0933Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromidePharmaceutical Associates, Inc.ANDACurrent
0121-0933Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromidePharmaceutical Associates, Inc.ANDACurrent
0121-0933Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromidePharmaceutical Associates, Inc.ANDACurrent
0121-0933Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromidePharmaceutical Associates, Inc.ANDACurrent
64376-657BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEPar PharmaceuticalANDACurrent
64376-657BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEPar PharmaceuticalANDACurrent