FDA.reportPublic FDA data

Application 085219

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085219-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALApproved before 1982

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
2026-08-01 22:54:322026-06A085219-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.0789baef-3424-43ab-a3fb-4908172da5652026-07-24Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm Drug57436cfa-9b94-89bf-e063-6394a90aa2642026-07-23Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEBryant Ranch Prepack03b7e52e-0003-47c3-af12-93ef00800b372026-07-16Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.cb7b7315-0170-492c-803f-60a6e75e55da2026-07-08Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.a85f69f5-ba97-478d-e053-2a95a90a0a972026-07-06Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnit Dose Solutions, Inc.54f027ea-0a6e-7920-e063-6394a90ab6ae2026-06-23Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy8a1de4e2-3aca-a4d3-e053-2995a90a1a412026-06-17Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLC8c868894-667e-4a51-906a-838d63e420ba2026-06-12Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy099496f1-4e2d-8d21-e063-6294a90af6952026-06-03Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepacka013211e-b8f8-426d-8e55-e86193f0634e2026-05-19Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackf22a10a2-8f84-4060-9143-427237c512802026-05-19Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack2b21f3fc-4164-401a-803e-b982dea97e192026-05-14Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.27a7e751-8aca-440e-95e4-cfecae1a24652026-05-13Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5ab641d8-cd22-4368-8070-18487dd801eb2026-05-11Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.99f45e08-897d-44dd-b48d-aa6d78981f0c2026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.918391e3-e8b3-4ceb-b4e7-c7c9617ea8822026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.2fd8f595-7aec-4308-bb17-a6f2e71900442026-04-15Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackff557069-f177-4e2e-91f4-675a033e27392026-04-14Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDECoupler LLC4ee35bcf-1eb0-1cca-e063-6294a90adeed2026-04-07Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE