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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Julphar
US Department of Justice
Dow
Deloitte
Chinese Patent Office
Fuji
Novartis
Covington
Cerilliant

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204498

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NDA 204498 describes FLUDEOXYGLUCOSE F18, which is a drug marketed by Downstate Clincl, 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, Cpdc, Essential Isotopes, Feinstein, Global Isotopes Llc, Hot Shots Nm Llc, Houston Cyclotron, Jubilant Draximage, Kettering Medctr, Kreitchman Pet Ctr, Lantheus Medical, Ma General Hosp, Mcprf, Mem Sloan-kettering, Methodist Hosp Res, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Petnet, Precision Nuclear, Queen Hamamatsu Pet, Shertech Labs Llc, Spectron Mrc Llc, Trustees Univ Pa, Ucla Biomedical, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Michigan, Univ North Dakota, Univ Tx Md Anderson, Univ Utah Cyclotron, Weill Medcl Coll, Wi Medcl Cyclotron, Wusm Cyclotron, and Zevacor Pharma Inc, and is included in forty-one NDAs. It is available from thirty-four suppliers. Additional details are available on the FLUDEOXYGLUCOSE F18 profile page.

The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.

Summary for 204498

Tradename:1
Applicant:1
Ingredient:1
Patents:0

Pharmacology for NDA: 204498

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 204498

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 204498 ANDA The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute 67939-010 67939-010-35 35 mL in 1 VIAL, MULTI-DOSE (67939-010-35)
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 204498 ANDA The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute 67939-010 67939-010-23 23 mL in 1 VIAL, MULTI-DOSE (67939-010-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20-300mCi/ML
Approval Date:Jun 23, 2015TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
Queensland Health
Baxter
Cipla
Teva
UBS
Fish and Richardson
Novartis
McKesson
Argus Health

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.

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