Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.