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Betaxolol Drug - Betaxolol The trade name of the product as shown on the labeling. Dosage - SOLUTION/DROPS; OPHTHALMIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Betaxolol Hydrochloride Multiple ingredients are in alphabetical order. Strength - EQ 0.5% BASE The potency of the active ingredient(s), Betaxolol Hydrochloride. May repeat for multiple part products. Applicant - AKORN The firm name holding legal responsibility for Betaxolol. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 075386 The FDA assigned number to Betaxolol. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Betaxolol. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AT The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Jun 30, 2000 The date Betaxolol 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 Betaxolol. 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 Betaxolol is in. Format is RX, OTC, DISCN. Applicant Full Name - Akorn Inc The full name of the firm holding legal responsibility for the new application of Betaxolol. Betaxolol Betamethasone Valerate Eq 0.1% Base Ointment; Topical Betatrex Eq 0.1% Base Ointment; Topical Beta-val Eq 0.1% Base Ointment; Topical Valisone Eq 0.1% Base Ointment; Topical Betaxolol Eq 0.5% Base Solution/drops; Ophthalmic Valisone Eq 0.1% Base Lotion; Topical Betamethasone Valerate Eq 0.1% Base Ointment; Topical Betamethasone Valerate Eq 0.1% Base Ointment; Topical Betamethasone Valerate Eq 0.1% Base Ointment; Topical Betamethasone Valerate Eq 0.1% Base Ointment; Topical NewDrugInformation