FDA.reportPublic FDA data

Application 207676

Type
ANDA
Sponsor
MAYNE PHARMA INC

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
51862-535brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromideMayne PharmaANDACurrent
51862-535brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromideMayne PharmaANDACurrent
51862-535brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromideMayne PharmaANDACurrent
51862-535brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromideMayne PharmaANDACurrent
51862-535brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromideMayne PharmaANDACurrent
68788-7610brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidePreferred Pharmaceuticals Inc.ANDACurrent
71205-346brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromideProficient Rx LPANDACurrent