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.
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 2026-08-01 22:54:32 2026-06 N201281-001 JENTADUETO 2.5MG;500MG TABLET / ORAL AB RLD 2012-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 JENTADUETO 2.5MG;850MG TABLET / ORAL AB RLD 2012-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 JENTADUETO 2.5MG;1GM TABLET / ORAL AB RLD, RS 2012-01-30 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 51 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N201281-001 8883805 2025-11-26 Drug product 2014-12-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 10022379 2029-04-02 U-2339 2018-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 10973827 2029-04-02 Drug product 2021-05-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 9415016 2029-04-02 Drug product 2016-08-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 10022379*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 10973827*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 9415016*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 11911388 2030-04-10 U-3854 2024-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 9155705 2030-05-21 Drug product 2015-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 8846695 2030-06-04 U-1503 2014-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 9155705*PED 2030-11-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 8846695*PED 2030-12-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-001 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 8883805 2025-11-26 Drug product 2014-12-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 10022379 2029-04-02 U-2339 2018-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 10973827 2029-04-02 Drug product 2021-05-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 9415016 2029-04-02 Drug product 2016-08-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 10022379*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 10973827*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 9415016*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 11911388 2030-04-10 U-3854 2024-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 9155705 2030-05-21 Drug product 2015-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 8846695 2030-06-04 U-1503 2014-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 9155705*PED 2030-11-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 8846695*PED 2030-12-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-002 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 8883805 2025-11-26 Drug product 2014-12-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 10022379 2029-04-02 U-2339 2018-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N201281-003 10973827 2029-04-02 Drug product 2021-05-05 a50c72e98297…
Observed Orange Book exclusivity history# 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