Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204546
Company: PRECISION NUCLEAR
Company: PRECISION NUCLEAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-500mCi/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 |
---|---|---|---|---|---|---|---|
04/07/2015 | ORIG-1 | Approval |
Label is not available on this site. |
FLUDEOXYGLUCOSE F18
INJECTABLE;INTRAVENOUS; 20-500mCi/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 | 20-500mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203603 | CARDINAL HEALTH 414 |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-500mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204546 | PRECISION NUCLEAR |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-500mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203665 | SOFIE |
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-500mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203709 | WISCONSIN |