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Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Fish and Richardson
Merck
Citi
Baxter
Chinese Patent Office
Federal Trade Commission
AstraZeneca
Express Scripts

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204546

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NDA 204546 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 204546
Tradename:FLUDEOXYGLUCOSE F18
Applicant:Precision Nuclear
Ingredient:fludeoxyglucose f-18
Patents:0
Pharmacology for NDA: 204546
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 204546
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 204546 ANDA Precision Nuclear LLC 52768-001 52768-001-50 50 mL in 1 VIAL (52768-001-50)
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 204546 ANDA Precision Nuclear LLC 52768-001 52768-001-30 30 mL in 1 VIAL (52768-001-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20-500mCi/ML
Approval Date:Apr 7, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Harvard Business School
Cipla
Federal Trade Commission
Chubb
Chinese Patent Office
US Department of Justice
Baxter

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