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Promethazine Hcl And Dextromethorphan Hydrobromide Drug - Promethazine Hcl And Dextromethorphan Hydrobromide The trade name of the product as shown on the labeling. Dosage - SYRUP; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Dextromethorphan Hydrobromide; Promethazine Hydrochloride Multiple ingredients are in alphabetical order. Strength - 15MG/5ML;6.25MG/5ML The potency of the active ingredient(s), Dextromethorphan Hydrobromide; Promethazine Hydrochloride. May repeat for multiple part products. Applicant - HI TECH PHARMA The firm name holding legal responsibility for Promethazine Hcl And Dextromethorphan Hydrobromide. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 040027 The FDA assigned number to Promethazine Hcl And Dextromethorphan Hydrobromide. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Promethazine Hcl And Dextromethorphan Hydrobromide. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AA The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Jul 31, 1996 The date Promethazine Hcl And Dextromethorphan Hydrobromide was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982". Reference Listed Drug (RLD) - No The pioneer or innovator of Promethazine Hcl And Dextromethorphan Hydrobromide. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - RX The group or category of approved drugs Promethazine Hcl And Dextromethorphan Hydrobromide is in. Format is RX, OTC, DISCN. Applicant Full Name - Hi Tech Pharmacal Co Inc The full name of the firm holding legal responsibility for the new application of Promethazine Hcl And Dextromethorphan Hydrobromide. Promethazine Hcl And Dextromethorphan Hydrobromide Mucinex Dm 30mg;600mg Tablet, Extended Release; Oral Mucinex Dm 60mg;1.2gm Tablet, Extended Release; Oral Phenergan W/ Dextromethorphan 15mg/5ml;6.25mg/5ml Syrup; Oral Pherazine Dm 15mg/5ml;6.25mg/5ml Syrup; Oral Prometh W/ Dextromethorphan 15mg/5ml;6.25mg/5ml Syrup; Oral Promethazine Hcl And Dextromethorphan Hydrobromide 15mg/5ml;6.25mg/5ml Syrup; Oral Dextroamphetamine Sulfate 5mg Tablet; Oral Dextrostat 10mg Tablet; Oral Dextrostat 5mg Tablet; Oral Ferndex 5mg Tablet; Oral NewDrugInformation