FDA.reportPublic FDA data

Application 209199

Type
ANDA
Sponsor
HETERO LABS LTD V

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
A209199-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2025-07-25
A209199-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2025-07-25
A209199-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2025-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209199-001AB
A209199-002AB
A209199-003AB

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 22:38:342026-08A209199-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2025-07-2584e616aacf4f…
2026-09-14 22:38:342026-08A209199-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-07-2584e616aacf4f…
2026-09-14 22:38:342026-08A209199-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2025-07-2584e616aacf4f…
2026-08-18 06:07:402026-07A209199-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A209199-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A209199-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2025-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209199-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2025-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209199-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209199-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2025-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209199-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2025-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209199-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209199-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2025-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209199-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2025-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209199-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2025-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209199-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2025-07-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209199-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2025-07-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209199-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-07-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209199-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2025-07-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209199-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209199-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209199-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A209199-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209199-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209199-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209199-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209199-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209199-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209199-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209199-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209199-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209199-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209199-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209199-003AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209199-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209199-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209199-003AB1a50c72e98297…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan medoxomil and hydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.d421f352-9500-4d3e-8bc3-0cdcc20505142025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209199
application number: ANDA209199

Reported adverse events (FAERS/openFDA)#

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