Details for New Drug Application (NDA): 203591
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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 203591
Tradename: | FLUDEOXYGLUCOSE F18 |
Applicant: | Sofie |
Ingredient: | fludeoxyglucose f-18 |
Patents: | 0 |
Pharmacology for NDA: 203591
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203591
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 203591 | ANDA | SOFIE Co. | 49609-101 | 49609-101-01 | 30 mL in 1 VIAL, MULTI-DOSE (49609-101-01) |
FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | INJECTABLE;INTRAVENOUS | 203591 | ANDA | SOFIE Co. | 49609-101 | 49609-101-02 | 50 mL in 1 VIAL, MULTI-DOSE (49609-101-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20-300mCi/ML | ||||
Approval Date: | Aug 31, 2015 | TE: | AP | RLD: | No |
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