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 43 .
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 · 86 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 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 43 · 1,698 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 N206073-001 8883805 2025-11-26 Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11033552 2027-05-04 Drug product 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12178819 2027-05-04 Drug product 2025-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7713938*PED 2027-10-15 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11033552*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8673927*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7579449 2028-08-01 Drug substance 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7579449*PED 2029-02-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8551957 2029-10-14 U-1651 Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12115179 2030-02-11 U-4023 2024-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8551957*PED 2030-04-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12115179*PED 2030-08-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 10258637 2034-04-03 U-2290 2019-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11090323 2034-04-03 U-3191 2021-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11833166 2034-04-03 U-3776 2024-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11833166 2034-04-03 U-3777 2024-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4304 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4293 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4294 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4295 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4296 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 9949998 2034-06-11 U-2290 2018-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 10258637*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11090323*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11833166*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12364700 2037-06-08 U-4224 2025-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12364700*PED 2037-12-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 8883805 2025-11-26 Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 11033552 2027-05-04 Drug product 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 12178819 2027-05-04 Drug product 2025-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 7713938*PED 2027-10-15 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 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.
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
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 · 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