Home Applications 017532 Application 017532
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIABETA GLYBURIDE TABLET;ORAL 1.25MG Yes No 002 DIABETA GLYBURIDE TABLET;ORAL 2.5MG Yes No 003 DIABETA GLYBURIDE TABLET;ORAL 5MG 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 N017532-001 DIABETA GLYBURIDE 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 N017532-002 DIABETA GLYBURIDE 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 N017532-003 DIABETA GLYBURIDE 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-9364 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9364 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9364 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9433 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9433 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9433 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9477 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9477 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-9477 Glyburide glyburide TEVA Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-433 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43353-656 Glyburide glyburide Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-656 Glyburide glyburide Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-659 Glyburide glyburide Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-659 Glyburide glyburide Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-895 Glyburide glyburide Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 55289-606 Glyburide glyburide PD-Rx Pharmaceuticals, In NDA AUTHORIZED Current 55289-606 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 55289-606 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 55289-606 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 55289-606 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 55289-606 Glyburide glyburide PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 68071-3097 Glyburide glyburide NuCare Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 70518-2695 Glyburide glyburide REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-2695 Glyburide glyburide REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-2695 Glyburide glyburide REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70934-409 Glyburide glyburide Denton Pharma, Inc. DBA Northwind Pharmaceuticals NDA AUTHORIZED GENERIC Current 70934-409 Glyburide glyburide Denton Pharma, Inc. DBA Northwind Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 46879 SUPPL 2017-01-18 46803 SUPPL 2017-01-11 11018 SUPPL 2013-10-21 622 SUPPL 2013-10-16 11017 SUPPL 2009-07-23 621 SUPPL 2009-07-15 33294 SUPPL 2009-03-17 11016 SUPPL 2009-03-17 13834 SUPPL 2009-03-10 620 SUPPL 2009-03-10