Application 077446

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGNoNo
002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;150MGTABLET / ORALAB2012-09-27
A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;300MGTABLET / ORALAB2012-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077446-001AB
A077446-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-2784e616aacf4f…
2026-09-14 22:38:342026-08A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-2784e616aacf4f…
2026-08-18 06:07:402026-07A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077446-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-09-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077446-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-09-2774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077446-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077446-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A077446-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077446-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077446-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077446-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077446-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077446-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077446-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077446-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077446-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077446-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077446-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077446-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077446-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077446-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077446-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077446-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077446-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077446-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077446-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077446-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077446-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077446-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077446-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077446-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077446-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077446-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077446-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077446-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077446-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077446-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077446-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077446-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077446-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077446-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077446-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077446-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077446-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077446-002AB174a2ff9319b5…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.88aaa2a1-13be-4f56-ace6-66e8990280072026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5eabb13d-f6fd-4091-9909-c4f0c59222892026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack85494404-484c-45a1-8487-f9eb2a76490d2026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke6c35575-9c3f-42f8-b8b8-577a29f9d3812026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5029c9f7-6233-4a6f-ace9-2268cc8e286d2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC72fa8cd4-bc2a-4a7d-8feb-2d60e077d8012026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53ce6e4f-db3a-4789-8bef-1e459fa78b792026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.83f4acc1-697a-4770-b554-1b9a8fb5de742026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e842fa14-b18e-4463-9bf1-a1c8700fe33c2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.181324c5-256f-4570-a0bb-8bc908deb2e22025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEHikma Pharmaceuticals USA Inc.17561aae-f0bc-4ffc-a007-985b17e9baf02025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46d77ed8-ece2-4f51-b1a4-4a440e2dce2d2025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1898f438-4571-4aab-ae06-9bf1aabf04862025-09-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc7ce5a69-1e07-4d52-b815-ce64ac3731ac2024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited9492a1cd-c012-4b43-931d-235220065e1e2023-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP97b09783-7bba-4f7a-b1b3-86ccf12c7ecc2021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc5f26357-40f3-49f4-99f2-845a8dda5f392019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irbesartan and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

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