Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021357
Company: BRACCO
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
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
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-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-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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.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-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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