FDA.reportPublic FDA data

Application 075579

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL2.5MG;6.25MGNoNo
002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MGNoNo
003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;6.25MGNoNo

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
A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25
A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25
A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075579-001AB
A075579-002AB
A075579-003AB

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 22:38:342026-08A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075579-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2000-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075579-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2000-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075579-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2000-09-25301d65b070ca…

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 22:38:342026-08A075579-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075579-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075579-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075579-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075579-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075579-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075579-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075579-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075579-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075579-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075579-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075579-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075579-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075579-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075579-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075579-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075579-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075579-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075579-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075579-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075579-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075579-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075579-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075579-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075579-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075579-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075579-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075579-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075579-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075579-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075579-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075579-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075579-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075579-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075579-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075579-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075579-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075579-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075579-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075579-001AB1301d65b070ca…

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscf088009-203e-4d70-b56e-b4062cf3fcd82023-05-19Warnings, Adverse reactionsName fallback
brand name: bisoprolol fumarate and hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limited35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa2022-11-07Name fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0707Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0707Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideEon Labs, Inc.ANDACurrent
21695-808Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideRebel Distributors CorpANDACurrent
21695-809Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideRebel Distributors CorpANDACurrent
63629-4072Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and HydrochlorothiazideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8723ORIG2004-05-28
8722ORIG2000-09-25