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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203155

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NDA 203155 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.

Summary for 203155

Tradename:	CHOLINE C-11
Applicant:	Mcprf
Ingredient:	choline c-11
Patents:	0

Pharmacology for NDA: 203155

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 203155

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	203155	NDA	Mayo Clinic	52670-556	52670-556-30	30 mL in 1 VIAL (52670-556-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	4-33.1mCi/ML
Approval Date:	Sep 12, 2012	TE:	AP	RLD:	Yes

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