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Generated: December 16, 2018

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Details for New Drug Application (NDA): 017042

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NDA 017042 describes FLUORINE F-18, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the FLUORINE F-18 profile page.

The generic ingredient in FLUORINE F-18 is sodium fluoride f-18. There are one thousand four hundred and fifty-four 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 017042
Tradename:FLUORINE F-18
Applicant:Ge Healthcare
Ingredient:sodium fluoride f-18
Formulation / Manufacturing:see details
Pharmacology for NDA: 017042
Mechanism of ActionRadiopharmaceutical Activity
Medical Subject Heading (MeSH) Categories for 017042
Suppliers and Packaging for NDA: 017042
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUORINE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 017042 NDA FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH 13267-542 13267-542-42 20 mL in 1 VIAL, GLASS (13267-542-42)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
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