Home Applications 020757 Application 020757
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AVAPRO IRBESARTAN TABLET;ORAL 75MG Yes No 002 AVAPRO IRBESARTAN TABLET;ORAL 150MG Yes No 003 AVAPRO IRBESARTAN TABLET;ORAL 300MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020757-001 AVAPRO IRBESARTAN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020757-002 AVAPRO IRBESARTAN 150MG TABLET / ORAL AB RLD 1997-09-30 N020757-003 AVAPRO IRBESARTAN 300MG TABLET / ORAL AB RLD, RS 1997-09-30
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 57 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5850 Avapro irbesartan sanofi-aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5850 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan sanofi-aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5851 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan sanofi-aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0024-5852 Avapro irbesartan Sanofi-Aventis U.S. LLC NDA Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1040 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1041 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1042 Irbesartan irbesartan Winthrop U.S. NDA AUTHORIZED GENERIC Current 35356-854 Avapro irbesartan Lake Erie Medical DBA Quality Care Products LLC NDA Current 50090-5055 Irbesartan irbesartan A-S Medication Solutions NDA AUTHORIZED GENERIC Current 50090-5055 Irbesartan irbesartan A-S Medication Solutions NDA AUTHORIZED GENERIC Current 50090-5055 Irbesartan irbesartan A-S Medication Solutions NDA AUTHORIZED GENERIC Current 71205-404 Irbesartan irbesartan Proficient Rx LP NDA AUTHORIZED GENERIC Current 71205-404 Irbesartan irbesartan Proficient Rx LP NDA AUTHORIZED GENERIC Current