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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
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