Details for New Drug Application (NDA): 206319
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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 206319
Tradename: | CHOLINE C-11 |
Applicant: | Decatur |
Ingredient: | choline c-11 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206319
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 206319
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHOLINE C-11 | choline c-11 | INJECTABLE;INTRAVENOUS | 206319 | ANDA | Decatur Memorial Hospital | 73410-004 | 73410-004-01 | 30 mL in 1 VIAL, MULTI-DOSE (73410-004-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 4-33.1mCi/ML | ||||
Approval Date: | Nov 13, 2015 | TE: | AP | RLD: | No |
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