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Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate Drug - Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate The trade name of the product as shown on the labeling. Dosage - TABLET, EXTENDED RELEASE; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Brompheniramine Maleate; Pseudoephedrine Hydrochloride Multiple ingredients are in alphabetical order. Strength - 16MG;240MG The potency of the active ingredient(s), Brompheniramine Maleate; Pseudoephedrine Hydrochloride. May repeat for multiple part products. Applicant - ALZA The firm name holding legal responsibility for Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 019672 The FDA assigned number to Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Mar 29, 1996 The date Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate 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) - Yes The pioneer or innovator of Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - OTC The group or category of approved drugs Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate is in. Format is RX, OTC, DISCN. Applicant Full Name - Alza Corp The full name of the firm holding legal responsibility for the new application of Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate. Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate Biphetap 4mg/5ml;25mg/5ml Elixir; Oral Bromanate 4mg/5ml;25mg/5ml Elixir; Oral Dimetapp 2mg/5ml;12.5mg/5ml Elixir; Oral Bromatapp 12mg;75mg Tablet, Extended Release; Oral Dimetapp 12mg;75mg Tablet, Extended Release; Oral Efidac 24 Pseudoephedrine Hcl/brompheniramine Maleate 16mg;240mg Tablet, Extended Release; Oral Bromanate Dm 2mg/5ml;10mg/5ml;30mg/5ml Syrup; Oral Bromfed-dm 2mg/5ml;10mg/5ml;30mg/5ml Syrup; Oral Dimetane-dx 2mg/5ml;10mg/5ml;30mg/5ml Syrup; Oral Myphetane Dx 2mg/5ml;10mg/5ml;30mg/5ml Syrup; Oral NewDrugInformation