Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021768
Company: WEILL MEDCL COLL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 10-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None No No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
08/05/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21768lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21768ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021768s000_FludeoxyglucoseTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2006 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021768s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/05/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21768lbl.pdf

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