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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021870
Company: FEINSTEIN

Products on NDA 021870

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-200mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-400mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021870

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2005	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	UNKNOWN	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021870lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021870ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021870s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021870Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021870Orig1s018ltr.pdf
06/27/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021870s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021870Orig1s015ltr.pdf
08/01/2016	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/08/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/15/2014	SUPPL-9	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021870Orig1s009ltr.pdf
11/28/2012	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/18/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021870s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021870s007ltr.pdf
01/05/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021870s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021870s005ltr.pdf
08/18/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021870s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021870s004ltr.pdf
12/21/2006	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for NDA 021870

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021870Orig1s018lbl.pdf
06/27/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021870s015lbl.pdf
01/18/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021870s007lbl.pdf
01/05/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021870s005lbl.pdf
08/18/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021870s004lbl.pdf
08/19/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021870lbl.pdf

Therapeutic Equivalents for NDA 021870

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 20-400mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-400mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021870	FEINSTEIN

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