Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021358
Company: BRACCO
Company: BRACCO
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 |
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 |
---|---|---|---|---|---|
07/23/2024 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s027,021358s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021357Orig1s027;021358Orig1s025ltr.pdf | |
08/14/2024 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s026,021358s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021357Orig1s026, 021358Orig1s024ltr.pdf | |
01/26/2024 | SUPPL-23 | Labeling-Medication Guide, 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-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-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-15 | 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-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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/14/2024 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s026,021358s024lbl.pdf | |
07/23/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s027,021358s025lbl.pdf | |
01/26/2024 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357Orig1s025; 021358Orig1s023correctedlbl.pdf | |
01/26/2024 | SUPPL-23 | Labeling-Package Insert | 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-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-15 | Labeling-Package Insert | 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 | |
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 |