Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022494
Company: NIH NCI DCTD

• Summary Review

Products on NDA 022494

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM FLUORIDE F 18	SODIUM FLUORIDE F-18	10-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022494s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000SumR.pdf