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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020306
Company: DOWNSTATE CLINCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2000 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_prntlbl.pdf
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