Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022494
Company: NIH NCI DCTD
Company: NIH NCI DCTD
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F 18 | SODIUM FLUORIDE F-18 | 10-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
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 |