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Details for New Drug Application (NDA): 203592

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NDA 203592 describes SODIUM FLUORIDE F-18, which is a drug marketed by Mcprf, Spectron Mrc Llc, Ncm Usa Bronx Llc, Shertech Labs Llc, Mips Crf, The Feinstein Inst, Hot Shots Nm Llc, Kreitchman Pet Ctr, Ucsf Rodiopharm, Midwest Medcl, Essential Isotopes, Precision Nuclear, Houston Cyclotron, Univ Tx Md Anderson, Biomedcl Res Fdn, Uihc Pet Imaging, Global Isotopes Llc, Triad Isotopes Inc, 3d Imaging Drug, Cardinal Health 414, Petnet, Zevacor Pharma Inc, 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 three hundred and fifty 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 NDA: 203592

Tradename:
SODIUM FLUORIDE F-18
Applicant:
Zevacor Pharma Inc
Ingredient:
sodium fluoride f-18
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203592

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 203592

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18
sodium fluoride f-18
INJECTABLE;INTRAVENOUS 203592 ANDA Zevacor Pharma, Inc. 49609-102 49609-102-01 30 mL in 1 VIAL, MULTI-DOSE (49609-102-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength10-200mCi/ML
Approval Date:Aug 18, 2015TE:APRLD:No


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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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