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Medtronic
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US Department of Justice
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Dow
Harvard Business School
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204513

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NDA 204513 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, Sofie, Spectron Mrc Llc, The Feinstein Inst, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Tx Md Anderson, and Univ Utah Cyclotron, 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 twenty-six 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 204513
Tradename:SODIUM FLUORIDE F-18
Applicant:Ncm Usa Bronx Llc
Ingredient:sodium fluoride f-18
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204513
Mechanism of ActionRadiopharmaceutical Activity
Medical Subject Heading (MeSH) Categories for 204513
Suppliers and Packaging for NDA: 204513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204513 ANDA NCM USA Bronx LLC 24445-623 N 24445-623-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength10-200mCi/ML
Approval Date:Nov 28, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cerilliant
QuintilesIMS
Accenture
Fish and Richardson
Dow
Colorcon
McKinsey
Merck

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