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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077354

KETOTIFEN FUMARATE (KETOTIFEN FUMARATE)
EQ 0.025% BASE
Marketing Status: Over-the-counter
Active Ingredient: KETOTIFEN FUMARATE
Proprietary Name: KETOTIFEN FUMARATE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 0.025% BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077354
Product Number: 001
Approval Date: May 9, 2006
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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