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Last Updated: January 17, 2020

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Details for New Drug Application (NDA): 208413

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NDA 208413 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 five 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. Five suppliers are listed for this compound. Additional details are available on the choline c-11 profile page.
Summary for 208413
Tradename:CHOLINE C-11
Applicant:Wa Univ Sch Med
Ingredient:choline c-11
Formulation / Manufacturing:see details
Pharmacology for NDA: 208413
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 208413
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLINE C-11 choline c-11 INJECTABLE;INTRAVENOUS 208413 ANDA Washington University School of Medicine 75913-311 75913-311-30 10 mL in 1 VIAL (75913-311-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength4-33.1mCi/ML
Approval Date:Jan 10, 2017TE:APRLD:No

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