Web NewDrugInformation.com

Didrex Drug - Didrex The trade name of the product as shown on the labeling. Dosage - TABLET; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Benzphetamine Hydrochloride Multiple ingredients are in alphabetical order. Strength - 25MG The potency of the active ingredient(s), Benzphetamine Hydrochloride. May repeat for multiple part products. Applicant - PHARMACIA AND UPJOHN The firm name holding legal responsibility for Didrex. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 012427 The FDA assigned number to Didrex. Format is nnnnnn. Product Number - 003 The FDA assigned number to identify Didrex. 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 - Approved Prior to Jan 1, 1982 The date Didrex 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 Didrex. 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 Didrex is in. Format is RX, OTC, DISCN. Applicant Full Name - Pharmacia And Upjohn Co The full name of the firm holding legal responsibility for the new application of Didrex. Didrex Ivy Block 5% Lotion; Topical Benzonatate 100mg Capsule; Oral Tessalon 100mg Capsule; Oral Tessalon 200mg Capsule; Oral Benzaclin 5%;eq 1% Base Gel; Topical Duac 5%;eq 1% Base Gel; Topical Benzamycin 5%;3% Gel; Topical Benzamycin Pak 5%;3% Gel; Topical Erythromycin And Benzoyl Peroxide 5%;3% Gel; Topical Didrex 25mg Tablet; Oral NewDrugInformation