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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019845

BETOPTIC S (BETAXOLOL HYDROCHLORIDE)
EQ 0.25% BASE
Marketing Status: Prescription
Active Ingredient: BETAXOLOL HYDROCHLORIDE
Proprietary Name: BETOPTIC S
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: EQ 0.25% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019845
Product Number: 001
Approval Date: Dec 29, 1989
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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