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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020186-001ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALABRLD1993-03-26
N020186-002ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26
N020186-003ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALABRLD1993-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020186-001AB
N020186-002AB
N020186-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020186-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020186-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020186-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N020186-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020186-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020186-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020186-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020186-001AB1301d65b070ca…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.27d52b23-e3e2-4339-b00e-cd0fec43ffbb2026-08-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020186
application number: NDA020186
ndc (product): 0093-3243
ndc (product): 0093-3241
ndc (product): 0093-3242
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscf088009-203e-4d70-b56e-b4062cf3fcd82023-05-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 020186
application number: NDA020186

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

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