Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021870

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FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
20-400mCi/ML
Marketing Status: Prescription

Active Ingredient: FLUDEOXYGLUCOSE F-18
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20-400mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021870
Product Number: 002
Approval Date: Nov 21, 2008
Applicant Holder Full Name: FEINSTEIN INSTITUTE MEDICAL RESEARCH
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: FLUDEOXYGLUCOSE F-18
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021870
Product Number: 001
Approval Date: Aug 19, 2005
Applicant Holder Full Name: FEINSTEIN INSTITUTE MEDICAL RESEARCH
Marketing Status:  Discontinued
Patent and Exclusivity Information