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Generated: October 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203936

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NDA 203936 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 eighteen 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 fifty-four drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sodium fluoride f-18 profile page.
Summary for 203936
Tradename:SODIUM FLUORIDE F-18
Applicant:Kreitchman Pet Ctr
Ingredient:sodium fluoride f-18
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203936
Mechanism of ActionRadiopharmaceutical Activity
Medical Subject Heading (MeSH) Categories for 203936
Suppliers and Packaging for NDA: 203936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 203936 ANDA Kreitchman PET Center 62072-500 62072-500-30 30 mL in 1 VIAL, MULTI-DOSE (62072-500-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength10-200mCi/ML
Approval Date:May 19, 2016TE:APRLD:No

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