.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203155

« Back to Dashboard
NDA 203155 describes CHOLINE C-11, which is a drug marketed by Global Isotopes Llc, Mcprf, and Univ Tx Md Anderson, and is included in three NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the choline c-11 profile page.

Summary for NDA: 203155

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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc