Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021768
Company: WEILL MEDCL COLL

Products on NDA 021768

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F18	FLUDEOXYGLUCOSE F-18	10-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021768

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

Labels for NDA 021768

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