Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021064
Company: LANTHEUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFINITY PERFLUTREN 6.52MG/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
07/31/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2018 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021064s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021064Orig1s022ltr.pdf
04/13/2018 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

01/19/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021064s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021064Orig1s020ltr.pdf
11/23/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/18/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021064Orig1s017ltr.pdf
02/05/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/24/2011 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021064s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011SumR.pdf
05/12/2008 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021064s009ltr.pdf
10/10/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021064s007ltr.pdf
05/06/2005 SUPPL-6 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf
01/30/2003 SUPPL-4 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21064scm004ltr.pdf
07/08/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064slr002ltr.pdf
02/21/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064s1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021064s022lbl.pdf
01/19/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021064s020lbl.pdf
08/18/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf
10/24/2011 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf
05/12/2008 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf
10/10/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf
05/06/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf
07/31/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English