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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203684
Company: BRACCO

Summary Review

Products on NDA 203684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMASON	SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES	60.7MG/25MG	FOR SUSPENSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203684Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203684s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203684Orig1s009ltr.pdf
12/02/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203684s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203684Orig1s007ltr.pdf
11/13/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203684s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203684Orig1s005ltr.pdf
12/22/2016	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203684Orig1s002ltr.pdf
03/31/2016	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203684Orig1s001ltr.pdf

Labels for NDA 203684

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203684s009lbl.pdf
12/02/2020	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203684s007lbl.pdf
12/02/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203684s007lbl.pdf
11/13/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203684s005lbl.pdf
12/22/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s002lbl.pdf
03/31/2016	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s001lbl.pdf
10/10/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000Lbl.pdf

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