Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203709
Company: WISCONSIN
Company: WISCONSIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 20-500mCi/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 |
|---|---|---|---|---|---|---|---|
| 12/23/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/19/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |