Home Applications 206111 Application 206111
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG Yes No 002 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;1GM Yes No 003 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;500MG Yes No 004 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206111-001 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL RLD 2015-08-26 N206111-002 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET / ORAL RLD 2015-08-26 N206111-003 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;500MG TABLET / ORAL RLD 2015-08-26 N206111-004 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;1GM TABLET / ORAL RLD, RS 2015-08-26
Orange Book patents# Current patent rows page 1 of 2 · 120 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 N206111-001 SYNJARDY 5MG;500MG TABLET / ORAL RLD 2015-08-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 SYNJARDY 5MG;1GM TABLET / ORAL RLD 2015-08-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-003 SYNJARDY 12.5MG;500MG TABLET / ORAL RLD 2015-08-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-004 SYNJARDY 12.5MG;1GM TABLET / ORAL RLD, RS 2015-08-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 120 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 N206111-001 7713938 2027-04-15 Drug substance, Drug product 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 7579449 2028-08-01 Drug substance 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10610489 2030-09-30 Drug product 2020-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10610489*PED 2031-03-30 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12527810 2033-04-22 U-4403 2026-02-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12527810*PED 2033-10-22 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10258637 2034-04-03 U-2290 2019-04-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11090323 2034-04-03 U-3193 2021-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11666590 2034-04-03 U-4154 2025-03-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11813275 2034-04-03 U-3759 2023-12-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11833166 2034-04-03 U-3776 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11833166 2034-04-03 U-3777 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12263153 2034-04-03 U-4154 2025-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12427162 2034-04-03 U-4287 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4304 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4293 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4294 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4295 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4296 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 9949997 2034-05-17 U-3532 2023-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 9949997 2034-05-17 U-3533 2023-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10258637*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11090323*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11813275*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11833166*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 9949997*PED 2034-11-17 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7713938 2027-04-15 Drug substance, Drug product 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7579449 2028-08-01 Drug substance 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 10610489 2030-09-30 Drug product 2020-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 10610489*PED 2031-03-30 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 12527810 2033-04-22 U-4403 2026-02-10 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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0159 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0159 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0159 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0159 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0159 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0168 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0168 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0168 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0168 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0168 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0175 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0175 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0175 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0175 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0175 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0180 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0180 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0180 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0180 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0180 Synjardy empagliflozin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current