FDA.reportPublic FDA data

Application 075642

Type
ANDA
Sponsor
APOTHECON

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27
A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27
A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075642-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORAL2000-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075642-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORAL2000-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075642-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2000-12-271e350fbaab3a…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53221419-204c-40a2-9ec3-8e4b994dd39d2026-08-20Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions12ba7eba-1874-41b6-aff5-7baba8b999842026-08-20Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba2026-08-19Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c2026-08-12Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.27d52b23-e3e2-4339-b00e-cd0fec43ffbb2026-08-11Warnings, Adverse reactionsName fallback
brand name: bisoprolol fumarate and hydrochlorothiazide
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.b9ee689a-ea12-435d-b01c-70d45891e62f2026-08-06Warnings, Adverse reactionsName fallback
brand name: bisoprolol fumarate and hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc57505d73-f2a8-430b-8703-a0a6bb733c7d2026-07-31Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEEdenbridge Pharmaceuticals LLC.295532b5-65c8-40c3-8d27-cfd334d128022026-07-02Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.d4243a76-516c-417e-80ba-444a21ecc6882026-05-12Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions9271a2d7-be94-4e38-9f71-41e8d55e10bc2026-03-03Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited2db1a899-f115-4da5-89fe-6e5b41086f6c2026-01-30Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions90bb2207-2eaf-495b-a222-c69d4db9e7a32026-01-14Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMarlex Pharmaceuticals, Inc.df881501-42ae-624a-e053-2995a90ab2a02025-09-23Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions6b7f96c3-daf4-4029-a96b-baa37add0edb2025-09-05Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack794d4a5a-de31-4878-95d5-23552dd2171e2025-06-04Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8d3e9c30-8dcf-491a-a515-6890b391398e2025-05-29Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGLENMARK PHARMACEUTICALS INC., USAab73a6d8-2e33-4fdc-a896-6c68ab772da62025-01-06Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack447c11b6-72fe-418e-a2db-5d90b53477962024-05-23Warnings, Adverse reactionsName fallback
brand name: bisoprolol fumarate and hydrochlorothiazide
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack36fbc5fc-4a75-4aa3-bed1-78944135ae112024-05-17Warnings, Adverse reactionsName fallback
brand name: bisoprolol fumarate and hydrochlorothiazide
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions78df389a-0916-46db-a536-72cae9ad6c082024-01-02Warnings, Adverse reactionsName fallback
brand name: Bisoprolol Fumarate and Hydrochlorothiazide

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30971ORIG2000-12-27