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Comtan Drug - Comtan 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) - Entacapone Multiple ingredients are in alphabetical order. Strength - 200MG The potency of the active ingredient(s), Entacapone. May repeat for multiple part products. Applicant - ORION The firm name holding legal responsibility for Comtan. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 020796 The FDA assigned number to Comtan. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Comtan. 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 - Oct 19, 1999 The date Comtan 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) - Yes The pioneer or innovator of Comtan. 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 Comtan is in. Format is RX, OTC, DISCN. Applicant Full Name - Orion Corp The full name of the firm holding legal responsibility for the new application of Comtan. Comtan Lovenox (preservative Free) 60mg/0.6ml (100mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 80mg/0.8ml (100mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 90mg/0.6ml (150mg/ml) **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Injectable; Subcutaneous Comtan 200mg Tablet; Oral Lovenox 300mg/3ml (100mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 100mg/ml (100mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 120mg/0.8ml (150mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 150mg/ml (150mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 30mg/0.3ml (100mg/ml) Injectable; Subcutaneous Lovenox (preservative Free) 40mg/0.4ml (100mg/ml) Injectable; Subcutaneous NewDrugInformation