Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021191
Company: VESSELON SPV LLC
Company: VESSELON SPV LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMAGENT | DIMYRISTOYL LECITHIN; PERFLEXANE | 0.92MG/VIAL;0.092MG/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/31/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21191ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-191_Imagent.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/21/2004 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21191sce001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/31/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21191lbl.pdf |