Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021191
Company: VESSELON SPV LLC

Products on NDA 021191

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021191

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

Labels for NDA 021191

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