An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021358
Company: BRACCO

Medication Guide

Other Important Information from FDA

Products on NDA 021358

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MULTIHANCE MULTIPACK	GADOBENATE DIMEGLUMINE	26.45GM/50ML (529MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes
MULTIHANCE MULTIPACK	GADOBENATE DIMEGLUMINE	52.9GM/100ML (529MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021358

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021358lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021358s000_021357s000_MultiHance.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357Orig1s025; 021358Orig1s023correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021357Orig1s025; 021358Orig1s023correctedltr.pdf
11/02/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s018,021358s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021489Orig1s010,021357Orig1s018,021358Orig1s017ltr.pdf
04/26/2018	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf
04/26/2018	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf
09/15/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021358s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021358Origs014ltr.pdf
01/19/2018	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s014,021358Orig1s013ltr.pdf
07/30/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021357Orig1s013,021358Orig1s012ltr.pdf
01/29/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/29/2011	SUPPL-10	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021358s010ltr.pdf
07/06/2012	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021358s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf
02/16/2011	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021358s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021358s008ltr.pdf
09/04/2007	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021357s003, 021358s003ltr.pdf
05/08/2007	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 021358

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357Orig1s025; 021358Orig1s023correctedlbl.pdf
01/26/2024	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357Orig1s025; 021358Orig1s023correctedlbl.pdf
11/02/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s018,021358s017lbl.pdf
04/26/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf
04/26/2018	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf
04/26/2018	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf
04/26/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf
01/19/2018	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf
09/15/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021358s014lbl.pdf
07/30/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf
07/06/2012	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021358s009lbl.pdf
02/16/2011	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021358s008lbl.pdf
09/04/2007	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf
11/23/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021358lbl.pdf

Top