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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021711
Company: LANTHEUS MEDCL

Other Important Information from FDA

Summary Review

Products on NDA 021711

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021711

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

Labels for NDA 021711

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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