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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Chinese Patent Office

Generated: December 12, 2017

DrugPatentWatch Database Preview

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, Univ Tx Md Anderson, and Wa Univ Sch Med, and is included in four NDAs. It is available from four 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 ninety-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the choline c-11 profile page.

Summary for 206319

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)

Summary 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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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo

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