FDA Approval Activities for this Drug…

Betagan (levobunolol HCl Liquidfilm) Allergan NDA 19-219/S20 8/8/01 4/15/03 Betagan (levobunolol HCl) liquifilm Allergan NDA 19-814/S12 8/8/01 6/10/03 Betagan (levobunolol HCl) liquifilm Allergan NDA 19-814/S11 Levobunolol Hydrochloride Ophthalmic Solution USP, 0.5%, Novex Pharma ANDA 75-475 8/3/00 11/6/00 Levobunolol Hydrochloride Ophthalmic Solution USP, 0.25%, Novex Pharma ANDA 75-473 LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.25% AKBETA Akorn 074780 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% AKBETA Akorn 019814 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.25% BETAGAN ALLERGAN 019219 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BETAGAN ALLERGAN 074307 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.25% LEVOBUNOLOL HCL BAUSCH AND LOMB 074326 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% LEVOBUNOLOL HCL BAUSCH AND LOMB 074851 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.25% LEVOBUNOLOL HCL FALCON 074850 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% LEVOBUNOLOL HCL FALCON 075473 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.25% LEVOBUNOLOL HCL Novex 075475 AT LEVOBUNOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% LEVOBUNOLOL HCL Novex

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