Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017243
Company: CURIUM
Company: CURIUM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ULTRA-TECHNEKOW FM | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 0.25-3 CI/GENERATOR | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| ULTRA-TECHNEKOW FM | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 1-19 CI/GENERATOR | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/04/2015 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf | |
| 02/18/2014 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf | |
| 12/20/2013 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf | |
| 10/15/2004 | SUPPL-25 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf |