Home Applications 208026 Application 208026
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JENTADUETO XR LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.5MG;1GM Yes No 002 JENTADUETO XR LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208026-001 JENTADUETO XR LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2016-05-27 N208026-002 JENTADUETO XR LINAGLIPTIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2016-05-27
Orange Book patents# Current patent rows page 1 of 1 · 36 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208026-001 8883805 2025-11-26 Drug product 2016-06-22 N208026-001 8883805*PED 2026-05-26 Pediatric extension N208026-001 8673927 2027-05-04 U-1503 Delist requested 2016-06-22 N208026-001 9173859 2027-05-04 U-1503 Drug product, Delist requested 2016-06-22 N208026-001 8673927*PED 2027-11-04 Pediatric extension N208026-001 9173859*PED 2027-11-04 Pediatric extension N208026-001 10022379 2029-04-02 U-2339 2018-08-06 N208026-001 9415016 2029-04-02 Drug product 2016-08-30 N208026-001 10022379*PED 2029-10-02 Pediatric extension N208026-001 9415016*PED 2029-10-02 Pediatric extension N208026-001 11911388 2030-04-10 U-3854 2024-03-25 N208026-001 9155705 2030-05-21 Drug product 2016-06-22 N208026-001 9155705*PED 2030-11-21 Pediatric extension N208026-001 9555001 2033-03-06 U-1967 Drug product 2017-02-22 N208026-001 9555001 2033-03-06 U-1968 Drug product 2017-02-22 N208026-001 9555001*PED 2033-09-06 Pediatric extension N208026-001 12364700 2037-06-08 U-4224 2025-07-31 N208026-001 12364700*PED 2037-12-08 Pediatric extension N208026-002 8883805 2025-11-26 Drug product 2016-06-22 N208026-002 8883805*PED 2026-05-26 Pediatric extension N208026-002 8673927 2027-05-04 U-1503 Delist requested 2016-06-22 N208026-002 9173859 2027-05-04 U-1503 Drug product, Delist requested 2016-06-22 N208026-002 8673927*PED 2027-11-04 Pediatric extension N208026-002 9173859*PED 2027-11-04 Pediatric extension N208026-002 10022379 2029-04-02 U-2339 2018-08-06 N208026-002 9415016 2029-04-02 Drug product 2016-08-30 N208026-002 10022379*PED 2029-10-02 Pediatric extension N208026-002 9415016*PED 2029-10-02 Pediatric extension N208026-002 11911388 2030-04-10 U-3854 2024-03-25 N208026-002 9155705 2030-05-21 Drug product 2016-06-22 N208026-002 9155705*PED 2030-11-21 Pediatric extension N208026-002 9555001 2033-03-06 U-1967 Drug product 2017-02-22 N208026-002 9555001 2033-03-06 U-1968 Drug product 2017-02-22 N208026-002 9555001*PED 2033-09-06 Pediatric extension N208026-002 12364700 2037-06-08 U-4224 2025-07-31 N208026-002 12364700*PED 2037-12-08 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 N208026-001 JENTADUETO XR 2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2016-05-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 JENTADUETO XR 5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2016-05-27 a50c72e98297…
Observed Orange Book patent history# 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 N208026-001 8883805 2025-11-26 Drug product 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 8673927 2027-05-04 U-1503 Delist requested 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9173859 2027-05-04 U-1503 Drug product, Delist requested 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9173859*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 10022379 2029-04-02 U-2339 2018-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9415016 2029-04-02 Drug product 2016-08-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 10022379*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9415016*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 11911388 2030-04-10 U-3854 2024-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9155705 2030-05-21 Drug product 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9155705*PED 2030-11-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9555001 2033-03-06 U-1967 Drug product 2017-02-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9555001 2033-03-06 U-1968 Drug product 2017-02-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 9555001*PED 2033-09-06 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 8883805 2025-11-26 Drug product 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 8673927 2027-05-04 U-1503 Delist requested 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9173859 2027-05-04 U-1503 Drug product, Delist requested 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9173859*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 10022379 2029-04-02 U-2339 2018-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9415016 2029-04-02 Drug product 2016-08-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 10022379*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9415016*PED 2029-10-02 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 11911388 2030-04-10 U-3854 2024-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9155705 2030-05-21 Drug product 2016-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9155705*PED 2030-11-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9555001 2033-03-06 U-1968 Drug product 2017-02-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9555001 2033-03-06 U-1967 Drug product 2017-02-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 9555001*PED 2033-09-06 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N208026-001 M-295 2026-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-001 PED 2026-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 M-295 2026-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N208026-002 PED 2026-12-20 a50c72e98297…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Jentadueto XR LINAGLIPTIN AND METFORMIN HYDROCHLORIDE Boehringer Ingelheim Pharmaceuticals, Inc. 3d02a4d4-d312-80b4-05c4-691b8f0aa7aa 2024-05-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208026 application number: NDA208026 ndc (product): 0597-0275 ndc (product): 0597-0270
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0270 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0270 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0270 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0270 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0275 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0275 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0275 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0275 Jentadueto XR linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current