Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203664
Company: PHARMALOGIC HLDGS
Company: PHARMALOGIC HLDGS
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 | 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 |
---|---|---|---|---|---|---|---|
02/04/2014 | ORIG-1 | Approval |
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 | 079086 | PETNET |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203664 | PHARMALOGIC HLDGS |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203801 | TRUSTEES UNIV PA |