FDA.reportPublic FDA data

Application 022425

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MULTAQDRONEDARONE HYDROCHLORIDETABLET;ORALEQ 400MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
0024-4142MultaqDronedaronesanofi-aventis U.S. LLCNDACurrent
53360-4142MultaqdronedaroneSanofi Winthrop IndustriesNDACurrent
55154-8104MultaqDronedaroneCardinal Health 107, LLCNDACurrent
55154-8104MultaqDronedaroneCardinal HealthNDACurrent
55154-8104MultaqDronedaroneCardinal HealthNDACurrent
55154-8104MultaqDronedaroneCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75923SUPPL 2023-10-25
75922SUPPL 2023-10-25
75921SUPPL 2023-10-25
75903SUPPL 2023-10-24
75902SUPPL 2023-10-24
65543SUPPL2020-12-09
65269SUPPL2020-11-18
65251SUPPL2020-11-17
56376SUPPL2018-11-08
7378SUPPL2016-02-16
17576SUPPL2014-06-23
7377SUPPL2014-04-03
7375SUPPL2014-03-20
7376SUPPL2014-02-04
38699SUPPL2014-01-31
17575SUPPL2013-04-01
7374SUPPL2013-03-29
38698SUPPL2012-09-11
38697SUPPL2012-09-11
17574SUPPL2012-09-11
29719SUPPL2012-09-10
29718SUPPL2012-09-10
7373SUPPL2012-09-10
17573SUPPL2012-06-18
29717SUPPL2012-06-15
38694SUPPL2012-01-31
29712SUPPL2012-01-30
29716SUPPL2011-12-21
17572SUPPL2011-12-19
38696SUPPL2011-09-07
7372SUPPL2011-09-06
7370SUPPL2011-08-11
17571SUPPL2011-06-29
7371SUPPL2011-06-27
29715SUPPL2011-03-14
38695SUPPL2011-03-11
38693SUPPL2011-02-24
29714SUPPL2011-02-15
29711SUPPL2011-02-15
29713SUPPL2011-02-04
17570SUPPL2011-01-31
23398ORIG2009-11-19
44752ORIG2009-08-20
22017ORIG2009-08-20
29710ORIG2009-07-30
38692ORIG2009-07-06