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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020485

VISINE (NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE)
0.025%;0.3%
Marketing Status: Over-the-counter
Active Ingredient: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Proprietary Name: VISINE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.025%;0.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020485
Product Number: 001
Approval Date: Jan 31, 1996
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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