Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210265
Company: UNIV TX SW MEDCTR
Company: UNIV TX SW MEDCTR
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 | 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 |
---|---|---|---|---|---|---|---|
02/06/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |