Details for New Drug Application (NDA): 021870
✉ Email this page to a colleague
The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.
Summary for 021870
Tradename: | FLUDEOXYGLUCOSE F18 |
Applicant: | Feinstein |
Ingredient: | fludeoxyglucose f-18 |
Patents: | 0 |
Pharmacology for NDA: 021870
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 021870
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 021870 | NDA | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | 13267-234 | 13267-234-45 | 25 mL in 1 VIAL, GLASS (13267-234-45) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 19, 2005 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-400mCi/ML | ||||
Approval Date: | Nov 21, 2008 | TE: | AP | RLD: | Yes |
Complete Access Available with Subscription