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Hydrocodone Bitartrate And Homatropine Methylbromide Drug - Hydrocodone Bitartrate And Homatropine Methylbromide The trade name of the product as shown on the labeling. Dosage - SYRUP; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Homatropine Methylbromide; Hydrocodone Bitartrate Multiple ingredients are in alphabetical order. Strength - 1.5MG/5ML;5MG/5ML The potency of the active ingredient(s), Homatropine Methylbromide; Hydrocodone Bitartrate. May repeat for multiple part products. Applicant - IVAX PHARMS The firm name holding legal responsibility for Hydrocodone Bitartrate And Homatropine Methylbromide. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 040285 The FDA assigned number to Hydrocodone Bitartrate And Homatropine Methylbromide. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Hydrocodone Bitartrate And Homatropine Methylbromide. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AA The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Jul 19, 1999 The date Hydrocodone Bitartrate And Homatropine Methylbromide 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 Hydrocodone Bitartrate And Homatropine Methylbromide. 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 Hydrocodone Bitartrate And Homatropine Methylbromide is in. Format is RX, OTC, DISCN. Applicant Full Name - Ivax Pharmaceuticals Inc The full name of the firm holding legal responsibility for the new application of Hydrocodone Bitartrate And Homatropine Methylbromide. Hydrocodone Bitartrate And Homatropine Methylbromide Homapin-10 10mg Tablet; Oral Homapin-5 5mg Tablet; Oral Hycodan 1.5mg/5ml;5mg/5ml Syrup; Oral Hydrocodone Bitartrate And Homatropine Methylbromide 1.5mg/5ml;5mg/5ml Syrup; Oral Histamine Phosphate Eq 1mg Base/ml Injectable; Injection Vantas 50mg Implant; Subcutaneous Supprelin Eq 0.2mg Base/ml Injectable; Injection Supprelin Eq 0.5mg Base/ml Injectable; Injection Supprelin Eq 1mg Base/ml Injectable; Injection Equipin 3mg Tablet, Chewable; Oral NewDrugInformation