Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021870
Company: FEINSTEIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML INJECTABLE;INTRAVENOUS Discontinued None Yes No
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-400mCi/ML INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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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