Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203137

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VIZAMYL (FLUTEMETAMOL F-18)
121.5mCi/30ML (4.05mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLUTEMETAMOL F-18
Proprietary Name: VIZAMYL
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 121.5mCi/30ML (4.05mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203137
Product Number: 002
Approval Date: Oct 25, 2013
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information
VIZAMYL (FLUTEMETAMOL F-18)
40.5mCi/10ML (4.05mCi/ML)
Marketing Status: Discontinued
Active Ingredient: FLUTEMETAMOL F-18
Proprietary Name: VIZAMYL
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 40.5mCi/10ML (4.05mCi/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203137
Product Number: 001
Approval Date: Oct 25, 2013
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information

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