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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022306

SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
150MG/10ML (15MG/ML)
Marketing Status: Prescription
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTALOL HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 150MG/10ML (15MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022306
Product Number: 001
Approval Date: Jul 2, 2009
Applicant Holder Full Name: ALTATHERA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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