Home Applications 020758 Application 020758
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Yes Yes 003 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Yes Yes 004 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020758-001 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020758-002 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 N020758-003 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 N020758-004 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avalide IRBESARTAN AND HYDROCHLOROTHIAZIDE Sanofi-Aventis U.S. LLC 0d91895e-c869-4b33-9b83-d55c1ad6317e 2025-10-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020758 application number: NDA020758 ndc (product): 0024-5855 ndc (product): 0024-5856
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 34 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5855 Avalide irbesartan and hydrochlorothiazide sanofi-aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide sanofi-aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5855 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide sanofi-aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide sanofi-aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0024-5856 Avalide irbesartan and hydrochlorothiazide Sanofi-Aventis U.S. LLC NDA Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1045 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1046 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Winthrop U.S. NDA AUTHORIZED GENERIC Current 71335-1392 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 71335-1392 Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current