Details for New Drug Application (NDA): 204546
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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 204546
Tradename: | FLUDEOXYGLUCOSE F18 |
Applicant: | Precision Nuclear |
Ingredient: | fludeoxyglucose f-18 |
Patents: | 0 |
Pharmacology for NDA: 204546
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 204546
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 204546 | ANDA | Precision Nuclear, LLC | 52768-001 | 52768-001-30 | 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30) / 30 mL in 1 VIAL, MULTI-DOSE |
FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 204546 | ANDA | Precision Nuclear, LLC | 52768-001 | 52768-001-50 | 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-500mCi/ML | ||||
Approval Date: | Apr 7, 2015 | TE: | AP | RLD: | No |
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