Application 204233

Type
ANDA
Sponsor
ALEMBIC PHARMS 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;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
A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2017-04-24
A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2017-04-24
A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204233-001AB
A204233-002AB
A204233-003AB

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 22:38:342026-08A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-2484e616aacf4f…
2026-09-14 22:38:342026-08A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-2484e616aacf4f…
2026-09-14 22:38:342026-08A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-2484e616aacf4f…
2026-08-18 06:07:402026-07A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204233-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204233-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204233-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-04-24301d65b070ca…

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 22:38:342026-08A204233-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204233-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204233-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A204233-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204233-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204233-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204233-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204233-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204233-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204233-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204233-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204233-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204233-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204233-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204233-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204233-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204233-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204233-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204233-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204233-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204233-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204233-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204233-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204233-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204233-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204233-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204233-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204233-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204233-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204233-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204233-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204233-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204233-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204233-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204233-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204233-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204233-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204233-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204233-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204233-001AB1301d65b070ca…

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.de815d64-b8d4-46a8-95b8-c230abe7f7672026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204233
application number: ANDA204233
ndc (product): 70518-2269
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.ca1a0aac-d81d-4c0a-91ea-cb719af772bf2025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204233
application number: ANDA204233
ndc (product): 62332-151
ndc (product): 62332-150
ndc (product): 62332-149
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke8a9dcaa-04e3-4f4e-a53d-42903e3da2d42024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204233
application number: ANDA204233
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited8c65d555-8db8-40d9-be30-309ef09f19be2023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204233
application number: ANDA204233
ndc (product): 46708-151
ndc (product): 46708-150
ndc (product): 46708-149

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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
50090-4878Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4878Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5909Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
62332-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-149Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-150Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-151Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
70518-2269Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2269Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2269Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2269Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2408Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2408Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2408Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2408Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent