FDA.reportPublic FDA data

Application 020591

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2MG;180MGYesNo
002TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL4MG;240MGYesYes
003TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1MG;240MGYesNo
004TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2MG;240MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3287TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3287TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3287TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3289TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3289TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3289TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3290TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3290TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
0074-3290TarkaTrandolapril and Verapamil HydrochlorideAbbVie Inc.NDACurrent
59762-0122Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0122Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0122Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0122Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0132Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0132Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0132Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0132Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0142Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0142Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0142Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent
59762-0142Trandolapril and Verapamil HydrochlorideTrandolapril and Verapamil HydrochlorideGreenstone LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59821SUPPL2019-08-22
59785SUPPL2019-08-21
49246SUPPL2017-08-04
49238SUPPL2017-08-04
25255SUPPL2016-07-13
12789SUPPL2016-07-13
34903SUPPL2016-02-02
2806SUPPL2016-02-01
12788SUPPL2015-01-08
2805SUPPL2014-12-30
34902SUPPL2012-09-14
25254SUPPL2012-09-14
25253SUPPL2012-01-30
12787SUPPL2012-01-23
2804SUPPL2011-11-16
34901SUPPL2011-11-14
34900SUPPL2011-09-16
25252SUPPL2011-09-16
2803SUPPL2011-08-31
12786SUPPL2011-08-29
25251SUPPL2009-03-06
2802SUPPL2008-03-04