Details for New Drug Application (NDA): 203155
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The generic ingredient in CHOLINE C-11 is choline c-11. There are one hundred and two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the choline c-11 profile page.
Summary for 203155
Tradename: | CHOLINE C-11 |
Applicant: | Mcprf |
Ingredient: | choline c-11 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203155
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203155
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHOLINE C-11 | choline c-11 | INJECTABLE;INTRAVENOUS | 203155 | NDA | Mayo Clinic | 52670-556 | 52670-556-30 | 30 mL in 1 VIAL (52670-556-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 4-33.1mCi/ML | ||||
Approval Date: | Sep 12, 2012 | TE: | AP | RLD: | Yes |
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