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Acetaminophen And Codeine Phosphate No. 4 Drug - Acetaminophen And Codeine Phosphate No. 4 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) - Acetaminophen; Codeine Phosphate Multiple ingredients are in alphabetical order. Strength - 300MG;60MG The potency of the active ingredient(s), Acetaminophen; Codeine Phosphate. May repeat for multiple part products. Applicant - ROXANE The firm name holding legal responsibility for Acetaminophen And Codeine Phosphate No. 4. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 084667 The FDA assigned number to Acetaminophen And Codeine Phosphate No. 4. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Acetaminophen And Codeine Phosphate No. 4. 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 Acetaminophen And Codeine Phosphate No. 4 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 Acetaminophen And Codeine Phosphate No. 4. 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 Acetaminophen And Codeine Phosphate No. 4 is in. Format is RX, OTC, DISCN. Applicant Full Name - Roxane Laboratories Inc The full name of the firm holding legal responsibility for the new application of Acetaminophen And Codeine Phosphate No. 4. Acetaminophen And Codeine Phosphate No. 4 Acetaminophen And Codeine Phosphate No. 2 300mg;15mg Tablet; Oral Acetaminophen And Codeine Phosphate No. 3 300mg;30mg Tablet; Oral Acetaminophen And Codeine Phosphate No. 3 300mg;30mg Tablet; Oral Acetaminophen And Codeine Phosphate No. 4 300mg;60mg Tablet; Oral Acetaminophen And Codeine Phosphate No. 4 300mg;60mg Tablet; Oral Acetaminophen And Codeine Phosphate No. 4 300mg;60mg Tablet; Oral Acetaminophen And Codeine Phosphate #3 300mg;30mg Tablet; Oral Acetaminophen And Codeine Phosphate #4 300mg;60mg Tablet; Oral Acetaminophen And Codeine Phosphate #4 300mg;60mg Tablet; Oral Acetaminophen And Codeine Phosphate No. 2 300mg;15mg Tablet; Oral NewDrugInformation