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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205690

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NDA 205690 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 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 205690
Tradename:CHOLINE C-11
Applicant:Univ Tx Md Anderson
Ingredient:choline c-11
Formulation / Manufacturing:see details
Pharmacology for NDA: 205690
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 205690
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLINE C-11 choline c-11 INJECTABLE;INTRAVENOUS 205690 ANDA The University of Texas MD Anderson Cancer Center 60215-110 E 60215-110-08
CHOLINE C-11 choline c-11 INJECTABLE;INTRAVENOUS 205690 ANDA The University of Texas MD Anderson Cancer Center 60215-111 N 60215-111-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength4-100mCi/ML
Approval Date:Oct 29, 2015TE:RLD:No

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