Home Applications 086881 Application 086881
Type ANDA
Sponsor YAOPHARMA CO LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A086881-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET / ORAL Approved 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.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A086881-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086881-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086881-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A086881-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL Approved before 1982 a50c72e98297…
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 · 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Safecor Health LLC 6fa96947-f4d8-4ca4-98fd-a2c123310d83 2026-06-29 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack c5258ea3-3aac-48fd-be5a-f8e4a47ca94a 2026-05-21 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack b3228678-7992-4148-b4ab-aa0d8b1b8570 2026-03-27 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 905568ae-ce27-4978-90c7-b5c93279ecd1 2026-03-12 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Mylan Pharmaceuticals Inc. 0c8c973f-13a2-4883-8316-4006398e2931 2026-03-11 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Prasco Laboratories 9d350fa2-d568-4970-a7a5-d128ff5d0a2f 2026-02-10 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Sun Pharmaceutical Industries, Inc. d7fa3c79-9f26-415b-8039-eb2acabcf66b 2025-12-09 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Mylan Institutional Inc. f2a4fbc0-650b-440d-9555-c1720fe0fe35 2025-07-22 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack d5387b26-90a3-44f0-850b-8aa1219fd26b 2025-06-26 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 3c9ceab1-75e9-47b0-a062-33d7d446b88a 2024-08-20 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack cc58a6a5-5ccd-451c-837c-781d0a8da5cf 2024-08-05 Warnings, Adverse reactions Name fallback brand name: Spironolactone and Hydrochlorothiazide
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.