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Triprolidine And Pseudoephedrine Hydrochlorides Drug - Triprolidine And Pseudoephedrine Hydrochlorides 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) - Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride Multiple ingredients are in alphabetical order. Strength - 120MG;5MG The potency of the active ingredient(s), Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride. May repeat for multiple part products. Applicant - KV PHARM The firm name holding legal responsibility for Triprolidine And Pseudoephedrine Hydrochlorides. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 072758 The FDA assigned number to Triprolidine And Pseudoephedrine Hydrochlorides. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Triprolidine And Pseudoephedrine Hydrochlorides. 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 - Nov 25, 1991 The date Triprolidine And Pseudoephedrine Hydrochlorides 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 Triprolidine And Pseudoephedrine Hydrochlorides. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - DISCN The group or category of approved drugs Triprolidine And Pseudoephedrine Hydrochlorides is in. Format is RX, OTC, DISCN. Applicant Full Name - Kv Pharmaceutical Co The full name of the firm holding legal responsibility for the new application of Triprolidine And Pseudoephedrine Hydrochlorides. Triprolidine And Pseudoephedrine Hydrochlorides Histafed 30mg/5ml;1.25mg/5ml Syrup; Oral Myfed 30mg/5ml;1.25mg/5ml Syrup; Oral Trilitron 30mg/5ml;1.25mg/5ml Syrup; Oral Triprolidine And Pseudoephedrine Hydrochlorides 120mg;5mg Tablet, Extended Release; Oral Pseudoephedrine Hcl 120mg Tablet, Extended Release; Oral Pseudoephedrine Hydrochloride 120mg Tablet, Extended Release; Oral Sudafed 12 Hour 120mg Tablet, Extended Release; Oral Actifed 120mg;5mg Capsule, Extended Release; Oral Triprolidine And Pseudoephedrine Hydrochlorides 120mg;5mg Capsule, Extended Release; Oral Actahist 30mg/5ml;1.25mg/5ml Syrup; Oral NewDrugInformation