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Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Healthtrust
Fuji
Cipla
Dow
Teva
Johnson and Johnson
Deloitte
McKinsey

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203155

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NDA 203155 describes CHOLINE C-11, which is a drug marketed by Wa Univ Sch Med, Global Isotopes Llc, Mcprf, and Univ Tx Md Anderson, 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 NDA: 203155

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203155

Mechanism of ActionRadiopharmaceutical 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength4-33.1mCi/ML
Approval Date:Sep 12, 2012TE:APRLD:Yes
Regulatory Exclusivity Expiration:Sep 12, 2017
Regulatory Exclusivity Use:EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Regulatory Exclusivity Expiration:Sep 12, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Accenture
Boehringer Ingelheim
Cerilliant
US Department of Justice
Deloitte
Fuji
AstraZeneca
Cantor Fitzgerald

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