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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 021357

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021357

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 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021357lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021357_021358_Multihance.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-25	Labeling-Package Insert	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-18	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-17	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
04/26/2018	SUPPL-16	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-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021357s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021357Orig1s015ltr.pdf
01/19/2018	SUPPL-14	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-13	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-12	Manufacturing (CMC)		Label is not available on this site.
07/06/2012	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021357s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf
12/20/2010	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s009ltr.pdf
03/17/2010	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s006ltr.pdf
10/02/2009	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021357s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021357s004ltr.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 021357

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-Medication Guide	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
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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