Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203137
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIZAMYL | FLUTEMETAMOL F-18 | 40.5mCi/10ML (4.05mCi/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
VIZAMYL | FLUTEMETAMOL F-18 | 121.5mCi/30ML (4.05mCi/ML) | INJECTABLE;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/25/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203137Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203137_vizamyl_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/10/2020 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203137s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203137Orig1s013ltr.pdf | |
02/22/2017 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203137s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203137Orig1s008ltr.pdf | |
11/21/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/07/2016 | SUPPL-5 | Labeling-Package Insert, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203137Orig1s005ltr.pdf | |
06/07/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203137Orig1s002ltr.pdf | |
02/03/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/10/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203137s013lbl.pdf | |
02/22/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203137s008lbl.pdf | |
04/07/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf | |
04/07/2016 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf | |
12/04/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf | |
10/25/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf |