FDA Approval Activities for this Drug…

Betaxolol Hydrochloride Tablets USP, 10 mg and 20 mg. Amide Pharmaceutical, ANDA 75-541 10/22/99 12/29/99 Betaxolol Ophthalmic Solution USP, 0.5%, Bausch & Lomb ANDA 75-630 4/12/01 4/13/01 Betaxolol Ophthalmic Solution USP, 0.5%, Bausch & Lomb ANDA 75-630 4/19/00 4/24/00 Betaxolol Ophthalmic Solution USP, 0.5%, Novex Pharma ANDA 75-446 9/28/00 10/30/00 Betaxolol Ophthalmic Solution USP, 0.5%, Akorn, ANDA 75-386 Betoptic S (betaxolol HCl ophthalmic suspension), 0.25%, Alcon NDA 19-845/S-017 BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETAXOLOL Akorn 019270 AT BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETOPTIC Alcon 075630 AT BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETAXOLOL HCL BAUSCH AND LOMB 075446 AT BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETAXOLOL Novex 019845 BETAXOLOL HYDROCHLORIDE Suspension/Drops; Ophthalmic 0.25% BASE BETOPTIC S Alcon 075541 BETAXOLOL HYDROCHLORIDE Tablet; 10MG BETAXOLOL HCL Amide 075541 BETAXOLOL HYDROCHLORIDE Tablet; 20MG BETAXOLOL HCL Amide 019507 BETAXOLOL HYDROCHLORIDE Tablet; 10MG KERLONE LOREX 019507 BETAXOLOL HYDROCHLORIDE Tablet; 20MG KERLONE LOREX

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