Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021711
Company: LANTHEUS MEDCL
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 |