Application 208847

Type
ANDA
Sponsor
UMEDICA LABS PVT LTD

Application Products#

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

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
A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2019-09-17
A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2019-09-17
A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2019-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208847-001AB
A208847-002AB
A208847-003AB

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 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-171e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208847-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208847-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208847-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208847-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208847-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208847-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208847-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208847-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208847-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208847-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208847-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208847-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208847-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208847-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208847-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208847-001AB11e350fbaab3a…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack77e71a2e-8370-4f7a-a5e4-93d86bd37dad2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208847
application number: ANDA208847
ndc (product): 71335-2180
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDELifestar Pharma LLC9771066e-c05d-6a93-e053-2995a90a7e872025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208847
application number: ANDA208847
ndc (product): 70756-814
ndc (product): 70756-812
ndc (product): 70756-813
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsba452478-f40c-446e-b61d-388379a55efd2023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208847
application number: ANDA208847
ndc (product): 50090-5450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5450Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-6027Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
70518-2834Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2834Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2861Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2861Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70756-812Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-812Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-812Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-812Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-812Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-812Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-813Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-813Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-813Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-813Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-813Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-813Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-814Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-814Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-814Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-814Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-814Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
70756-814Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLCANDACurrent
71335-2180Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideBryant Ranch PrepackANDACurrent