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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019270

BETOPTIC (BETAXOLOL HYDROCHLORIDE)
EQ 0.5% BASE
Marketing Status: Prescription
Active Ingredient: BETAXOLOL HYDROCHLORIDE
Proprietary Name: BETOPTIC
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 0.5% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N019270
Product Number: 001
Approval Date: Aug 30, 1985
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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