FDA.reportPublic FDA data

Application 205292

Type
ANDA
Sponsor
PADDOCK LLC

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
0574-1104Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromidePaddock Laboratories, LLCANDACurrent
0574-1104Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromidePadagis US LLCANDACurrent
50090-5625Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideA-S Medication SolutionsANDACurrent
63187-664Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideProficient Rx LPANDACurrent
63187-664Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideProficient Rx LPANDACurrent
63629-8615Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBryant Ranch PrepackANDACurrent
63629-8615Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBryant Ranch PrepackANDACurrent
63629-8615Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBryant Ranch PrepackANDACurrent
63629-8616Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBryant Ranch PrepackANDACurrent
63629-8616Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBryant Ranch PrepackANDACurrent
63629-8616Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBryant Ranch PrepackANDACurrent
68788-6453Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6453Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromidePreferred Pharmaceuticals Inc.ANDACurrent