Web NewDrugInformation.com

Aspirin And Caffeine W/ Butalbital Drug - Aspirin And Caffeine W/ Butalbital 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) - Aspirin; Butalbital; Caffeine Multiple ingredients are in alphabetical order. Strength - 325MG;50MG;40MG The potency of the active ingredient(s), Aspirin; Butalbital; Caffeine. May repeat for multiple part products. Applicant - PUREPAC PHARM The firm name holding legal responsibility for Aspirin And Caffeine W/ Butalbital. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 086710 The FDA assigned number to Aspirin And Caffeine W/ Butalbital. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Aspirin And Caffeine W/ Butalbital. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AB The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Aug 23, 1983 The date Aspirin And Caffeine W/ Butalbital 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 Aspirin And Caffeine W/ Butalbital. 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 Aspirin And Caffeine W/ Butalbital is in. Format is RX, OTC, DISCN. Applicant Full Name - Purepac Pharmaceutical Co The full name of the firm holding legal responsibility for the new application of Aspirin And Caffeine W/ Butalbital. Aspirin And Caffeine W/ Butalbital Butalbital, Aspirin And Caffeine 325mg;50mg;40mg Capsule; Oral Fiorinal 325mg;50mg;40mg Capsule; Oral Lanorinal 325mg;50mg;40mg Capsule; Oral Aspirin And Caffeine W/ Butalbital 325mg;50mg;40mg Tablet; Oral M.V.I.-12 Lyophilized 100mg/vial;0.06mg/vial;0.005mg/vial;15mg/vial;5ugm/vial;0.4mg/vial;40mg/vial;4mg/vial;3.6mg/vial;3mg/vial;1mg/vial;10mg/vial Injectable; Injection Vitaped N/a,80mg/vial;n/a,0.02mg/vial;n/a,0.001mg/vial;400 Iu/10ml,n/a;n/a,0.14mg/vial;n/a,17mg/vial;n/a,5mg/vial;0.2mg/10ml,n/a;n/a,1mg/vial;n/a,1.4mg/vial;n/a,1.2mg/vial;eq 2,300 Units Base/10ml,n/a;7 Iu/10ml,n/a Injectable; Injection 8-hour Bayer 650mg Tablet, Extended Release; Oral Measurin 650mg Tablet, Extended Release; Oral Bayer Extra Strength Aspirin For Migraine Pain 500mg Tablet; Oral Axotal 650mg;50mg Tablet; Oral NewDrugInformation