FDA.reportPublic FDA data

Application 020186

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MGYesNo
002ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;6.25MGYesYes
003ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL2.5MG;6.25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazideTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-040Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-047Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent
51285-050Ziacbisoprolol fumarate and hydrochlorothiazideTeva Women's Health, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77159SUPPL 2023-12-27
77133SUPPL 2023-12-27
66727SUPPL2021-03-10
66465SUPPL2021-03-03
64385SUPPL2020-08-24
64344SUPPL2020-08-21
34355SUPPL2011-05-05
12309SUPPL2010-08-12
24553SUPPL2010-01-19
34354SUPPL2009-11-19
24552SUPPL2007-09-26
24551SUPPL2004-07-01
41210SUPPL2001-08-01