Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203612
Company: MCPRF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-240mCi/ML INJECTABLE;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/05/2013 ORIG-1 Approval

Label is not available on this site.

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 20-240mCi/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 20-240mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203612 MCPRF

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