Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017771
Company: SHINE
Company: SHINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNELITE | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 0.0083-2.7 CI/GENERATOR | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| TECHNELITE | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 1-20 CI/GENERATOR | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/20/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017771Orig1s044lbl.pdf | |
| 01/20/2023 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017771Orig1s044lbl.pdf | |
| 02/12/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf |