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Amikin In Sodium Chloride 0.9% In Plastic Container Drug - Amikin In Sodium Chloride 0.9% In Plastic Container The trade name of the product as shown on the labeling. Dosage - INJECTABLE; INJECTION The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Amikacin Sulfate Multiple ingredients are in alphabetical order. Strength - EQ 10MG BASE/ML The potency of the active ingredient(s), Amikacin Sulfate. May repeat for multiple part products. Applicant - APOTHECON The firm name holding legal responsibility for Amikin In Sodium Chloride 0.9% In Plastic Container. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 050618 The FDA assigned number to Amikin In Sodium Chloride 0.9% In Plastic Container. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Amikin In Sodium Chloride 0.9% In Plastic Container. 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 - Nov 30, 1987 The date Amikin In Sodium Chloride 0.9% In Plastic Container 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 Amikin In Sodium Chloride 0.9% In Plastic Container. 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 Amikin In Sodium Chloride 0.9% In Plastic Container is in. Format is RX, OTC, DISCN. Applicant Full Name - Apothecon Inc Div Bristol Myers Squibb The full name of the firm holding legal responsibility for the new application of Amikin In Sodium Chloride 0.9% In Plastic Container. Amikin In Sodium Chloride 0.9% In Plastic Container Amikin Eq 250mg Base/ml Injectable; Injection Amikin Eq 250mg Base/ml Injectable; Injection Amikin Eq 250mg Base/ml Injectable; Injection Amikin Eq 50mg Base/ml Injectable; Injection Amikin Eq 50mg Base/ml Injectable; Injection Amikin Eq 50mg Base/ml Injectable; Injection Amikin In Sodium Chloride 0.9% In Plastic Container Eq 10mg Base/ml Injectable; Injection Amikacin Sulfate Eq 250mg Base/ml Injectable; Injection Amikacin Sulfate Eq 50mg Base/ml Injectable; Injection Amikacin Sulfate In Sodium Chloride 0.9% In Plastic Container Eq 500mg Base/100ml Injectable; Injection NewDrugInformation