Details for New Drug Application (NDA): 206319
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NDA 206319 describes CHOLINE C-11, which is a drug marketed by Decatur, Mcprf, Ucsf Rodiopharm, Univ Tx Md Anderson, and Wa Univ Sch Med, and is included in five NDAs. It is available from two suppliers. Additional details are available on the CHOLINE C-11 profile page.
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.
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 |
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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