Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022425
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 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
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
11/16/2020 SUPPL-29 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide 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
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-Modified, REMS-Assessment 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
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
11/16/2020 SUPPL-29 Labeling-Medication Guide 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-Modified 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-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

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