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Teva
Fish and Richardson
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Queensland Health
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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204542

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NDA 204542 describes SODIUM FLUORIDE F-18, which is a drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Cardinal Health 414, Essential Isotopes, Global Isotopes Llc, Hot Shots Nm Llc, Houston Cyclotron, Jubilant Draximage, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Petnet, Precision Nuclear, Shertech Labs Llc, Spectron Mrc Llc, The Feinstein Inst, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Tx Md Anderson, Univ Utah Cyclotron, and Zevacor Pharma Inc, and is included in twenty-three NDAs. It is available from seventeen suppliers. Additional details are available on the SODIUM FLUORIDE F-18 profile page.

The generic ingredient in SODIUM FLUORIDE F-18 is sodium fluoride f-18. There are one thousand four hundred and fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sodium fluoride f-18 profile page.
Summary for 204542
Tradename:SODIUM FLUORIDE F-18
Applicant:Precision Nuclear
Ingredient:sodium fluoride f-18
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204542
Mechanism of ActionRadiopharmaceutical Activity
Medical Subject Heading (MeSH) Categories for 204542
Suppliers and Packaging for NDA: 204542
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204542 ANDA Precision Nuclear LLC 52768-125 N 52768-125-50
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204542 ANDA Precision Nuclear LLC 52768-125 N 52768-125-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength10-200mCi/ML
Approval Date:Feb 27, 2015TE:APRLD:No

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US Army
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