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Generated: November 19, 2018

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Details for New Drug Application (NDA): 203591

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NDA 203591 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, Sofie, 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, and Wusm Cyclotron, and is included in forty-one NDAs. It is available from thirty-five 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-five suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.
Summary for 203591
Tradename:FLUDEOXYGLUCOSE F18
Applicant:Sofie
Ingredient:fludeoxyglucose f-18
Patents:0
Pharmacology for NDA: 203591
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 203591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 203591 ANDA SOFIE Co. 49609-101 49609-101-01 30 mL in 1 VIAL, MULTI-DOSE (49609-101-01)
FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 203591 ANDA SOFIE Co. 49609-101 49609-101-02 50 mL in 1 VIAL, MULTI-DOSE (49609-101-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20-300mCi/ML
Approval Date:Aug 31, 2015TE:APRLD:No

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