Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203544
Company: SOFIE
Company: SOFIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 | 10-200mCi/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 |
---|---|---|---|---|---|---|---|
12/26/2012 | ORIG-1 | Approval |
Label is not available on this site. |