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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078208

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE)
0.02675%;0.315%
Marketing Status: Over-the-counter
Active Ingredient: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Proprietary Name: NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.02675%;0.315%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078208
Product Number: 001
Approval Date: Sep 27, 2010
Applicant Holder Full Name: ALTAIRE PHARMACEUTICALS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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