Home Applications 206073 Application 206073
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLYXAMBI EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 10MG;5MG Yes No 002 GLYXAMBI EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 25MG;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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206073-001 GLYXAMBI EMPAGLIFLOZIN; LINAGLIPTIN 10MG;5MG TABLET / ORAL RLD 2015-01-30 N206073-002 GLYXAMBI EMPAGLIFLOZIN; LINAGLIPTIN 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30
Orange Book patents# Current patent rows page 1 of 1 · 64 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 3 · 82 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 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 40 · 1,570 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 N206073-001 8883805 2025-11-26 Drug product 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 8883805*PED 2026-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11033552 2027-05-04 Drug product 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12178819 2027-05-04 Drug product 2025-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 7713938*PED 2027-10-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11033552*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 8673927*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 7579449 2028-08-01 Drug substance 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 7579449*PED 2029-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 8551957 2029-10-14 U-1651 Drug product 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12115179 2030-02-11 U-4023 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 8551957*PED 2030-04-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12115179*PED 2030-08-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 10258637 2034-04-03 U-2290 2019-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11090323 2034-04-03 U-3191 2021-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11833166 2034-04-03 U-3776 2024-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11833166 2034-04-03 U-3777 2024-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12433906 2034-04-03 U-4304 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12433906 2034-04-03 U-4293 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12433906 2034-04-03 U-4294 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12433906 2034-04-03 U-4295 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12433906 2034-04-03 U-4296 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 9949998 2034-06-11 U-2290 2018-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 10258637*PED 2034-10-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11090323*PED 2034-10-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 11833166*PED 2034-10-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12433906*PED 2034-10-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12364700 2037-06-08 U-4224 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-001 12364700*PED 2037-12-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 8883805 2025-11-26 Drug product 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 8883805*PED 2026-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 11033552 2027-05-04 Drug product 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 12178819 2027-05-04 Drug product 2025-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 7713938*PED 2027-10-15 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Glyxambi EMPAGLIFLOZIN AND LINAGLIPTIN Boehringer Ingelheim Pharmaceuticals, Inc. ddbab689-f76c-488c-9613-4168d41dd730 2026-01-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 206073 application number: NDA206073 ndc (product): 0597-0182 ndc (product): 0597-0164
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0164 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0182 Glyxambi empagliflozin and linagliptin Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 70518-2046 Glyxambi empagliflozin and linagliptin REMEDYREPACK INC. NDA Current 70518-2046 Glyxambi empagliflozin and linagliptin REMEDYREPACK INC. NDA Current 70518-2046 Glyxambi empagliflozin and linagliptin REMEDYREPACK INC. NDA Current