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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017318

SODIUM ROSE BENGAL I 131 (ROSE BENGAL SODIUM I-131)
0.5mCi/ML
Marketing Status: Discontinued
Active Ingredient: ROSE BENGAL SODIUM I-131
Proprietary Name: SODIUM ROSE BENGAL I 131
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5mCi/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017318
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SORIN BIOMEDICA SPA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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