Home Applications 201281 Application 201281
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG Yes No 002 JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;850MG Yes No 003 JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;1GM 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 N201281-001 JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 N201281-002 JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 N201281-003 JENTADUETO LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 51 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 observed states.
Observed Orange Book patent history# Patent history page 1 of 43 · 1,710 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N201281-001 8883805 2025-11-26 Drug product 2014-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 8883805*PED 2026-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 8673927*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 10022379 2029-04-02 U-2339 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 10973827 2029-04-02 Drug product 2021-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 9415016 2029-04-02 Drug product 2016-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 10022379*PED 2029-10-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 10973827*PED 2029-10-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 9415016*PED 2029-10-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 11911388 2030-04-10 U-3854 2024-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 9155705 2030-05-21 Drug product 2015-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 8846695 2030-06-04 U-1503 2014-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 9155705*PED 2030-11-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 8846695*PED 2030-12-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 12364700 2037-06-08 U-4224 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-001 12364700*PED 2037-12-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 8883805 2025-11-26 Drug product 2014-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 8883805*PED 2026-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 8673927*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 10022379 2029-04-02 U-2339 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 10973827 2029-04-02 Drug product 2021-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 9415016 2029-04-02 Drug product 2016-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 10022379*PED 2029-10-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 10973827*PED 2029-10-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 9415016*PED 2029-10-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 11911388 2030-04-10 U-3854 2024-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 9155705 2030-05-21 Drug product 2015-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 8846695 2030-06-04 U-1503 2014-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 9155705*PED 2030-11-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 8846695*PED 2030-12-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 12364700 2037-06-08 U-4224 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-002 12364700*PED 2037-12-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 8883805 2025-11-26 Drug product 2014-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 8883805*PED 2026-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 8673927*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 10022379 2029-04-02 U-2339 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201281-003 10973827 2029-04-02 Drug product 2021-05-05 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 222 observed states.
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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0146 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0146 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0146 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0146 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0147 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0147 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0147 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0147 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0148 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0148 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0148 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0148 Jentadueto linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 63629-6524 Jentadueto linagliptin and metformin hydrochloride Bryant Ranch Prepack NDA Current 63629-6524 Jentadueto linagliptin and metformin hydrochloride Bryant Ranch Prepack NDA Current