Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203605
Company: MCPRF
Company: MCPRF
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 | 10-91.5mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/28/2013 | ORIG-1 | Approval |
Label is not available on this site. |