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FDA Approval Activities for this Drug…
ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Ciba Vision NDA 21-066 7/2/99 7/6/99 7/6/99 3/31/02 ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Ciba Vision NDA 21-066/S4 07/20/01 05/08/03 ZADITOR Indication: for the prevention of itching of the eye due to allergic conjunctivitis. KETOTIFEN FUMARATE Solution/Drops; Ophthalmic 0.025% BASE ZADITOR NOVARTIS | Ketotifen Fumarate Ophthalmic Solution, Alcon, Tentative Approval | Ketotifen Fumarate Ophthalmic Solution, Apotex, Approval | Zaditor (ketotifen fumarate ophthalmic solution), Novartis Pharma, Labeling Revision | Alaway (ketotifen fumarate ophthalmic solution), Alimera Sciences, Approval | Alaway Ophthalmic Solution, Bausch & Lomb Inc., Package Change | Ketotifen Fumarate Ophthalmic Solution, Akorn Inc., Approval | Zaditor (ketotifen fumarate) Ophthalmic Solution, Novartis Pharmaceuticals Corp., Labeling Revision | Ketotifen Fumarate Ophthalmic Solution, Alcon Inc., Approval
  
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