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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020306
Company: DOWNSTATE CLINCL

Products on NDA 020306

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FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	4-40mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	4-90mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020306

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.

Labels for NDA 020306

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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