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… FML (fluorometholone ophthalmic solution, USP) 0.1%, Allergan, NDA 16-851/S-051 6/28/01 11/25/02 6/16/03 FML (fluorometholone ophthalmic ointment) 0.1%. Allergan, NDA FLUOROMETHOLONE Ointment; Ophthalmic 0.1% FML ALLERGAN 016851 FLUOROMETHOLONE Suspension/Drops; Ophthalmic 0.1% FML ALLERGAN 019216 FLUOROMETHOLONE Suspension/Drops; Ophthalmic 0.25% FML FORTE ALLERGAN 070185 FLUOROMETHOLONE Suspension; Ophthalmic 0.1% FLUOR-OP NOVARTIS 019079 FLUOROMETHOLONE ACETATE Suspension/Drops; Ophthalmic 0.1% FLAREX Alcon 050628 FLUOROMETHOLONE ACETATE; TOBRAMYCIN Suspension/Drops; Ophthalmic 0.1%;0.3% TOBRASONE Alcon 019525 FLUOROMETHOLONE; SULFACETAMIDE SODIUM Suspension/Drops; Ophthalmic 0.1%;10% FML-S ALLERGAN 17-760/S-009 | FML-S (fluorometholone and sulfacetamide sodium) ophthalmic suspension, Allergan, Manufacturing Change or Addition | FML FORTE (fluorometholone ophthalmic suspension, USP), Allergan, Package Change & Labeling Revision | Flarex (fluorometholone acetate ophthalmic suspension), Alcon Labs, Labeling Revision | FML (fluorometholone) Ophthalmic Ointment, Allergan, Inc., Package Change ^ 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