Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079086
Company: PETNET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML INJECTABLE;INTRAVENOUS Prescription AP No 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
02/25/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079086s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 20-200mCi/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 20-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203664 LANTHEUS MEDICAL
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 079086 PETNET
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203801 TRUSTEES UNIV PA

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