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Serving leading biopharmaceutical companies globally:

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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203664

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NDA 203664 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 203664

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

Pharmacology for NDA: 203664

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 203664

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 203664 ANDA Lantheus Medical Imaging, Inc. 11994-015 11994-015-01 25 mL in 1 VIAL, MULTI-DOSE (11994-015-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20-200mCi/ML
Approval Date:Feb 4, 2014TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Dow
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Daiichi Sankyo
Fish and Richardson
Fuji
Mallinckrodt
Accenture
Deloitte

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