Details for New Drug Application (NDA): 203811
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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 203811
Tradename: | FLUDEOXYGLUCOSE F18 |
Applicant: | Ucla Biomedical |
Ingredient: | fludeoxyglucose f-18 |
Patents: | 0 |
Pharmacology for NDA: 203811
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203811
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 203811 | ANDA | University of California, Los Angeles | 76394-3811 | 76394-3811-3 | 30 mL in 1 VIAL, MULTI-DOSE (76394-3811-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 4-40mCi/ML | ||||
Approval Date: | Jun 27, 2013 | TE: | AP | RLD: | No |
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