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Generated: December 15, 2018

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Details for New Drug Application (NDA): 206319

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NDA 206319 describes CHOLINE C-11, which is a drug marketed by Global Isotopes Llc, 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 206319
Tradename:CHOLINE C-11
Applicant:Global Isotopes Llc
Ingredient:choline c-11
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206319
Mechanism of ActionRadiopharmaceutical 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 Global Isotopes, LLC d/b/a Zevacor Molecular 69126-004 69126-004-01 30 mL in 1 VIAL, MULTI-DOSE (69126-004-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength4-33.1mCi/ML
Approval Date:Nov 13, 2015TE:APRLD:No

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