Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019829
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CERETEC | TECHNETIUM TC-99M EXAMETAZIME KIT | N/A | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/19/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf | |
| 09/19/2018 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf | |
| 08/05/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf |