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.
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 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 64 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 N206073-001 8883805 2025-11-26 Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11033552 2027-05-04 Drug product 2021-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12178819 2027-05-04 Drug product 2025-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11033552*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7579449 2028-08-01 Drug substance 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8551957 2029-10-14 U-1651 Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8551957*PED 2030-04-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 10258637 2034-04-03 U-2290 2019-04-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11090323 2034-04-03 U-3191 2021-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11833166 2034-04-03 U-3776 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11833166 2034-04-03 U-3777 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4304 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4293 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4294 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4295 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4296 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 9949998 2034-06-11 U-2290 2018-05-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 10258637*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11090323*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11833166*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 8883805 2025-11-26 Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 11033552 2027-05-04 Drug product 2021-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 12178819 2027-05-04 Drug product 2025-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 7713938*PED 2027-10-15 Pediatric extension 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 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