Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205108

SOTYLIZE (SOTALOL HYDROCHLORIDE)
5MG/ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTYLIZE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205108
Product Number: 001
Approval Date: Oct 22, 2014
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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