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 43 .
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 · 54 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 · 129 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 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 observed states.
Observed Orange Book patent history# Patent history page 1 of 46 · 1,818 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N201281-001 8883805 2025-11-26 Drug product 2014-12-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 8673927*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 10022379 2029-04-02 U-2339 2018-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 10973827 2029-04-02 Drug product 2021-05-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 12678442 2029-04-02 Drug product 2026-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 9415016 2029-04-02 Drug product 2016-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 10022379*PED 2029-10-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 10973827*PED 2029-10-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 9415016*PED 2029-10-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 11911388 2030-04-10 U-3854 2024-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 9155705 2030-05-21 Drug product 2015-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 8846695 2030-06-04 U-1503 2014-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 9155705*PED 2030-11-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 8846695*PED 2030-12-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 12364700 2037-06-08 U-4224 2025-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-001 12364700*PED 2037-12-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 8883805 2025-11-26 Drug product 2014-12-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 8673927*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 10022379 2029-04-02 U-2339 2018-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 10973827 2029-04-02 Drug product 2021-05-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 12678442 2029-04-02 Drug product 2026-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 9415016 2029-04-02 Drug product 2016-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 10022379*PED 2029-10-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 10973827*PED 2029-10-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 9415016*PED 2029-10-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 11911388 2030-04-10 U-3854 2024-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 9155705 2030-05-21 Drug product 2015-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 8846695 2030-06-04 U-1503 2014-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 9155705*PED 2030-11-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 8846695*PED 2030-12-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 12364700 2037-06-08 U-4224 2025-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-002 12364700*PED 2037-12-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-003 8883805 2025-11-26 Drug product 2014-12-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-003 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-003 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201281-003 8673927*PED 2027-11-04 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 234 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.
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 · 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