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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021357
Company: BRACCO

Medication Guide

Other Important Information from FDA

Products on NDA 21357

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MULTIHANCE	GADOBENATE DIMEGLUMINE	2.645GM/5ML (529MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes
MULTIHANCE	GADOBENATE DIMEGLUMINE	5.29GM/10ML (529MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes
MULTIHANCE	GADOBENATE DIMEGLUMINE	7.935GM/15ML (529MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes
MULTIHANCE	GADOBENATE DIMEGLUMINE	10.58GM/20ML (529MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes

Labels for NDA 021357

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2024	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s026,021358s024lbl.pdf
07/23/2024	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s027,021358s025lbl.pdf
01/26/2024	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357Orig1s025; 021358Orig1s023correctedlbl.pdf
11/02/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s018,021358s017lbl.pdf
04/26/2018	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf
04/26/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.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
01/19/2018	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf
09/15/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021357s015lbl.pdf
07/30/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf
07/06/2012	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021357s011lbl.pdf
12/20/2010	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s009lbl.pdf
03/17/2010	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s006lbl.pdf
10/02/2009	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021357s004lbl.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/2004/021357lbl.pdf

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