Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021711
Company: LANTHEUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABLAVAR GADOFOSVESET TRISODIUM 2440MG/10ML (244MG/ML) SOLUTION;INTRAVENOUS Discontinued None No No
ABLAVAR GADOFOSVESET TRISODIUM 3660MG/15ML (244MG/ML) SOLUTION;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
12/22/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021711s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/07/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021711Orig1s004ltr.pdf
12/20/2010 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s003ltr.pdf
01/11/2010 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/07/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf
12/20/2010 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s003lbl.pdf
01/11/2010 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s001lbl.pdf

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