Drugs@FDA: FDA Approved Drug Products

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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F18 FLUDEOXYGLUCOSE F-18 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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F18 FLUDEOXYGLUCOSE F-18 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
08/19/1994 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/2000 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306s005Fludeoxyglucose.cfm
08/30/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/05/1997 SUPPL-2 Labeling

Label is not available on this site.

08/13/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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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