Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020372
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYOVIEW | TECHNETIUM TC-99M TETROFOSMIN KIT | N/A | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| MYOVIEW 30ML | TECHNETIUM TC-99M TETROFOSMIN 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 |
|---|---|---|---|---|---|
| 12/06/2022 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s033lbl.pdf | |
| 12/06/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s033lbl.pdf | |
| 03/09/2022 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s031lbl.pdf | |
| 03/09/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s031lbl.pdf | |
| 04/17/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020372s028lbl.pdf | |
| 02/26/2009 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf | |
| 02/26/2009 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf | |
| 07/07/2005 | SUPPL-19 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf | |
| 11/13/2003 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20372slr015_myoview_lbl.pdf | |
| 02/28/2003 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020372s013lbl.pdf | |
| 11/23/2001 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_prntlbl.pdf | |
| 08/27/2001 | SUPPL-9 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf |