Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022425
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MULTAQ | DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2009 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022425s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/23/2023 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022425s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022425Orig1s028, s030ltr.pdf | |
| 11/16/2020 | SUPPL-29 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022425Orig1s029ltr.pdf | |
| 10/23/2023 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022425s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022425Orig1s028, s030ltr.pdf | |
| 02/12/2016 | SUPPL-27 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022425Orig1s027ltr.pdf |
| 03/19/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s025ltr.pdf | |
| 03/19/2014 | SUPPL-24 | REMS-Assessment |
Label is not available on this site. |
||
| 01/30/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s023ltr.pdf | |
| 03/19/2014 | SUPPL-22 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s022ltr.pdf |
| 03/27/2013 | SUPPL-21 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022425s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022425Orig1s021ltr.pdf | |
| 09/07/2012 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf | |
| 09/07/2012 | SUPPL-17 | REMS-Assessment, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf | |
| 09/07/2012 | SUPPL-16 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf | |
| 06/13/2012 | SUPPL-14 | REMS-Modified, REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s014ltr.pdf | |
| 12/19/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s013ltr.pdf | |
| 08/22/2011 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s012ltr.pdf | |
| 06/21/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s010ltr.pdf | |
| 03/11/2011 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s007ltr.pdf | |
| 08/05/2011 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s006ltr.pdf |
| 02/11/2011 | SUPPL-5 | Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s005ltr.pdf |
| 01/31/2011 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s004ltr.pdf | |
| 01/25/2012 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s002ltr.pdf | |
| 02/11/2011 | SUPPL-1 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/23/2023 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022425s028s030lbl.pdf | |
| 10/23/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022425s028s030lbl.pdf | |
| 11/16/2020 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf | |
| 11/16/2020 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf | |
| 11/16/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf | |
| 03/31/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf | |
| 01/30/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s023lbl.pdf | |
| 03/27/2013 | SUPPL-21 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022425s021lbl.pdf | |
| 09/07/2012 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf | |
| 09/07/2012 | SUPPL-17 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf | |
| 09/07/2012 | SUPPL-17 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf | |
| 09/07/2012 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf | |
| 06/13/2012 | SUPPL-14 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s014lbl.pdf | |
| 06/13/2012 | SUPPL-14 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s014lbl.pdf | |
| 01/25/2012 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s002lbl.pdf | |
| 12/19/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s013lbl.pdf | |
| 08/22/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s012lbl.pdf | |
| 06/21/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s010lbl.pdf | |
| 03/11/2011 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s007lbl.pdf | |
| 02/11/2011 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s001lbl.pdf | |
| 01/31/2011 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s004lbl.pdf | |
| 07/01/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf |
MULTAQ
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DRONEDARONE HYDROCHLORIDE | DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 205904 | LUPIN |
| MULTAQ | DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022425 | SANOFI AVENTIS US |