Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021191
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

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