FDA.reportPublic FDA data

Application 200532

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL12.5MG;20MGNoNo
002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL12.5MG;40MGNoNo
003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL25MG;40MGNoNo

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
A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORAL2017-04-24
A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORAL2017-04-24
A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORAL2017-04-24

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 22:38:342026-08A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-2484e616aacf4f…
2026-09-14 22:38:342026-08A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-2484e616aacf4f…
2026-09-14 22:38:342026-08A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-2484e616aacf4f…
2026-08-18 06:07:402026-07A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200532-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200532-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200532-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-04-24301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A200532-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200532-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200532-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200532-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200532-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200532-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200532-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200532-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200532-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200532-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200532-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200532-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200532-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200532-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200532-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200532-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200532-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200532-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200532-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200532-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200532-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200532-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200532-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200532-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200532-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200532-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200532-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200532-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200532-002AB1cb3db0bc1861…

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENorthStar RxLLC364af4fe-cde8-466f-b56f-d93d532b56f52025-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4a2c2b8f-1479-4555-9ba8-ca44070032962024-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsfe49d96e-5874-4b11-9323-b4a92e9c25dc2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions3df6c955-9c38-4e44-a665-dac2a051bd022024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsb78ad43f-f132-4f03-8c85-2cf9b3ab555b2024-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke8a9dcaa-04e3-4f4e-a53d-42903e3da2d42024-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4c0b028d-f0f4-417f-a068-dca24e56113f2024-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsad1b2af1-3713-4776-bf48-d776073d97812024-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions13a03209-c73c-4254-be19-d1f8884cc6622023-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsba452478-f40c-446e-b61d-388379a55efd2023-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited8c65d555-8db8-40d9-be30-309ef09f19be2023-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil 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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7615Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7615Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7616Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7616Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7617Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7617Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3053Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3348Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
63629-7278Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7278Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideBryant Ranch PrepackANDACurrent