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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 021870


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NDA 021870 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, Decatur, Essential Isotopes, Feinstein, Hot Shots Nm Llc, Isologic Innovative, Jubilant Draximage, Kettering Medctr, Kreitchman Pet Ctr, Ma General Hosp, Mcprf, Mem Sloan-kettering, Methodist Hosp Res, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Northland, Nukemed, Petnet, Pharmalogic, Pharmalogic Hldgs, Precision Nuclear, Queen Hamamatsu Pet, Sofie, Trustees Univ Pa, Ucla Biomedical, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Michigan, Univ Southern Ca, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Utah Cyclotron, Weill Medcl Coll, Wisconsin, and Wusm Cyclotron, and is included in forty-three NDAs. It is available from twenty-seven 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.
Summary for 021870
Tradename:FLUDEOXYGLUCOSE F18
Applicant:Feinstein
Ingredient:fludeoxyglucose f-18
Patents:0
Pharmacology for NDA: 021870
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 021870
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 021870 NDA THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH 13267-234 13267-234-45 25 mL in 1 VIAL, GLASS (13267-234-45)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 19, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20-400mCi/ML
Approval Date:Nov 21, 2008TE:APRLD:Yes

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