Product Details for NDA 020306
FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; INJECTION
Strength: 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020306
Product Number: 001
Approval Date: Aug 19, 1994
Applicant Holder Full Name: DOWNSTATE CLINICAL PET CENTER
Marketing Status: Discontinued
Patent and Exclusivity Information
FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020306
Product Number: 001
Approval Date: Aug 19, 1994
Applicant Holder Full Name: DOWNSTATE CLINICAL PET CENTER
Marketing Status: Discontinued
Patent and Exclusivity Information
4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; INJECTION
Strength: 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020306
Product Number: 002
Approval Date: Sep 25, 2001
Applicant Holder Full Name: DOWNSTATE CLINICAL PET CENTER
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4-90mCi/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: N020306
Product Number: 002
Approval Date: Sep 25, 2001
Applicant Holder Full Name: DOWNSTATE CLINICAL PET CENTER
Marketing Status: Discontinued
Patent and Exclusivity Information