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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204315

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NDA 204315 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 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 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 204315

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204315

Mechanism of ActionRadiopharmaceutical Activity

Medical Subject Heading (MeSH) Categories for 204315

Suppliers and Packaging for NDA: 204315

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204315 ANDA Shertech Laboratories, LLC 16129-002 16129-002-30 30 mL in 1 VIAL, MULTI-DOSE (16129-002-30)
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204315 ANDA Shertech Laboratories, LLC 16129-002 16129-002-10 10 mL in 1 VIAL, MULTI-DOSE (16129-002-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength10-200mCi/ML
Approval Date:Sep 22, 2014TE:APRLD:No


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