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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203912

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NDA 203912 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 203912

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

Pharmacology for NDA: 203912

Mechanism of ActionRadiopharmaceutical Activity

Medical Subject Heading (MeSH) Categories for 203912

Suppliers and Packaging for NDA: 203912

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 203912 ANDA Spectron mrc, LLC 13108-211 13108-211-25 1 mL in 1 VIAL, GLASS (13108-211-25)
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 203912 ANDA Spectron mrc, LLC 13108-211 13108-211-10 1 mL in 1 VIAL, GLASS (13108-211-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength10-200mCi/ML
Approval Date:Apr 22, 2015TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
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Moodys
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Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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