Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com