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Terramycin W/ Polymyxin Drug - Terramycin W/ Polymyxin The trade name of the product as shown on the labeling. Dosage - OINTMENT; OTIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Oxytetracycline Hydrochloride; Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - EQ 5MG BASE/GM;10,000 UNITS/GM The potency of the active ingredient(s), Oxytetracycline Hydrochloride; Polymyxin B Sulfate. May repeat for multiple part products. Applicant - PFIZER The firm name holding legal responsibility for Terramycin W/ Polymyxin. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 061841 The FDA assigned number to Terramycin W/ Polymyxin. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Terramycin W/ Polymyxin. 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 Terramycin W/ Polymyxin 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 Terramycin W/ Polymyxin. 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 Terramycin W/ Polymyxin is in. Format is RX, OTC, DISCN. Applicant Full Name - Pfizer Laboratories Div Pfizer Inc The full name of the firm holding legal responsibility for the new application of Terramycin W/ Polymyxin. Terramycin W/ Polymyxin Terramycin Eq 500mg Base/vial Injectable; Injection Terramycin W/ Polymyxin B Sulfate Eq 5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Terramycin W/ Polymyxin Eq 5mg Base/gm;10,000 Units/gm Ointment; Otic Oxytetracycline Hcl Eq 250mg Base Capsule; Oral Oxytetracycline Hcl Eq 250mg Base Capsule; Oral Oxytetracycline Hcl Eq 250mg Base Capsule; Oral Oxytetracycline Hcl Eq 250mg Base Capsule; Oral Terramycin Eq 125mg Base Capsule; Oral Terramycin Eq 250mg Base Capsule; Oral Terramycin Eq 250mg Base/vial Injectable; Injection NewDrugInformation