FDA.reportPublic FDA data

Application 208465

Type
ANDA
Sponsor
SCIEGEN PHARMS

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 1.

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
A208465-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2026-03-31
A208465-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2026-03-31
A208465-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2026-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208465-001AB
A208465-002AB
A208465-003AB

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-03-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-03-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-003AB1a50c72e98297…

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 · 2 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 reactionsExact identifier
application applno (ANDA): 208465
application number: ANDA208465
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc52332190-2a12-d205-e063-6394a90ab7c52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208465
application number: ANDA208465