FDA.reportPublic FDA data

Application 206371

Type
ANDA
Sponsor
MICRO LABS

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
A206371-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2026-04-13
A206371-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2026-04-13
A206371-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2026-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206371-001AB
A206371-002AB
A206371-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206371-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A206371-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A206371-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-04-1384e616aacf4f…
2026-08-18 06:07:402026-07A206371-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A206371-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A206371-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-04-13caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206371-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-04-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206371-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-04-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206371-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-04-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206371-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206371-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206371-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A206371-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206371-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206371-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206371-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206371-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206371-003AB1a50c72e98297…

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.574d2679-c036-fa12-e063-6394a90aef332026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc52332190-2a12-d205-e063-6394a90ab7c52026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack77e71a2e-8370-4f7a-a5e4-93d86bd37dad2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack68d44330-4213-46a7-97b9-f858c16454d12026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack78eb9041-a738-4056-8705-8c1dd13a4da42026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack2c8bb018-af07-4745-a4e9-f9a6795a5ea22026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackbb362b67-4a14-4491-9e12-0f7d5c7a65bc2026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackde2d4628-08b3-4e31-aacc-ed85897f52e32026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack89f525cb-fa15-4407-8cbf-14e7f6bf90552026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.de815d64-b8d4-46a8-95b8-c230abe7f7672026-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLCbdca31d3-60b1-4659-aef7-56530b4f90392025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDELifestar Pharma LLC9771066e-c05d-6a93-e053-2995a90a7e872025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAccord Healthcare Inc.d858a6de-dda5-4bcd-a255-5723d01d896f2025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Olmesartan medoxomil and hydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.d421f352-9500-4d3e-8bc3-0cdcc20505142025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan medoxomil and hydrochlorothiazide
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack0360db3a-17cf-4d24-97ba-e0a6fcc943512025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.ca1a0aac-d81d-4c0a-91ea-cb719af772bf2025-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions5c4c5907-36f0-461e-b0c9-d51edff32a972025-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsf7415f1d-98c7-454f-bb1a-f59e95652c882025-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited744c1785-42b2-46a5-b0f4-2887a9ec20512025-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil and Hydrochlorothiazide
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c7472025-05-22Boxed 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.