Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216023
Company: BLUE EARTH
Company: BLUE EARTH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POSLUMA | FLOTUFOLASTAT F-18 GALLIUM | 25ML (8-158mCi/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
05/25/2023 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216023Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216023Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/25/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf |