Application 206111

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGYesNo
002SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;1GMYesNo
003SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL12.5MG;500MGYesNo
004SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL12.5MG;1GMYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206111-001SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALRLD2015-08-26
N206111-002SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;1GMTABLET / ORALRLD2015-08-26
N206111-003SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE12.5MG;500MGTABLET / ORALRLD2015-08-26
N206111-004SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE12.5MG;1GMTABLET / ORALRLD, RS2015-08-26

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206111-00177139382027-04-15Drug substance, Drug product2015-09-30
N206111-0017713938*PED2027-10-15Pediatric extension
N206111-00175794492028-08-01Drug substance2015-09-30
N206111-0017579449*PED2029-02-01Pediatric extension
N206111-001121151792030-02-11U-40232024-11-12
N206111-00112115179*PED2030-08-11Pediatric extension
N206111-001106104892030-09-30Drug product2020-05-01
N206111-00110610489*PED2031-03-30Pediatric extension
N206111-001125278102033-04-22U-44032026-02-10
N206111-00112527810*PED2033-10-22Pediatric extension
N206111-001102586372034-04-03U-22902019-04-30
N206111-001110903232034-04-03U-31932021-08-20
N206111-001116665902034-04-03U-41542025-03-28
N206111-001118132752034-04-03U-37592023-12-13
N206111-001118331662034-04-03U-37762024-01-03
N206111-001118331662034-04-03U-37772024-01-03
N206111-001122631532034-04-03U-41542025-04-29
N206111-001124271622034-04-03U-42872025-10-29
N206111-001124339062034-04-03U-42932025-10-29
N206111-001124339062034-04-03U-42942025-10-29
N206111-001124339062034-04-03U-42952025-10-29
N206111-001124339062034-04-03U-42962025-10-29
N206111-001124339062034-04-03U-43042025-10-29
N206111-00199499972034-05-17U-35322023-03-01
N206111-00199499972034-05-17U-35332023-03-01
N206111-00110258637*PED2034-10-03Pediatric extension
N206111-00111090323*PED2034-10-03Pediatric extension
N206111-00111813275*PED2034-10-03Pediatric extension
N206111-00111833166*PED2034-10-03Pediatric extension
N206111-00112433906*PED2034-10-03Pediatric extension
N206111-0019949997*PED2034-11-17Pediatric extension
N206111-00277139382027-04-15Drug substance, Drug product2015-09-30
N206111-0027713938*PED2027-10-15Pediatric extension
N206111-00275794492028-08-01Drug substance2015-09-30
N206111-0027579449*PED2029-02-01Pediatric extension
N206111-002121151792030-02-11U-40232024-11-12
N206111-00212115179*PED2030-08-11Pediatric extension
N206111-002106104892030-09-30Drug product2020-05-01
N206111-00210610489*PED2031-03-30Pediatric extension
N206111-002125278102033-04-22U-44032026-02-10
N206111-00212527810*PED2033-10-22Pediatric extension
N206111-002102586372034-04-03U-22902019-04-30
N206111-002110903232034-04-03U-31932021-08-20
N206111-002116665902034-04-03U-41542025-03-28
N206111-002118132752034-04-03U-37592023-12-13
N206111-002118331662034-04-03U-37762024-01-03
N206111-002118331662034-04-03U-37772024-01-03
N206111-002122631532034-04-03U-41542025-04-29
N206111-002124271622034-04-03U-42872025-10-29
N206111-002124339062034-04-03U-42932025-10-29
N206111-002124339062034-04-03U-42942025-10-29
N206111-002124339062034-04-03U-42952025-10-29
N206111-002124339062034-04-03U-42962025-10-29
N206111-002124339062034-04-03U-43042025-10-29
N206111-00299499972034-05-17U-35322023-03-01
N206111-00299499972034-05-17U-35332023-03-01
N206111-00210258637*PED2034-10-03Pediatric extension
N206111-00211090323*PED2034-10-03Pediatric extension
N206111-00211813275*PED2034-10-03Pediatric extension
N206111-00211833166*PED2034-10-03Pediatric extension
N206111-00212433906*PED2034-10-03Pediatric extension
N206111-0029949997*PED2034-11-17Pediatric extension
N206111-00377139382027-04-15Drug substance, Drug product2015-09-30
N206111-0037713938*PED2027-10-15Pediatric extension
N206111-00375794492028-08-01Drug substance2015-09-30
N206111-0037579449*PED2029-02-01Pediatric extension
N206111-003121151792030-02-11U-40232024-11-12
N206111-00312115179*PED2030-08-11Pediatric extension
N206111-003106104892030-09-30Drug product2020-05-01
N206111-00310610489*PED2031-03-30Pediatric extension
N206111-003125278102033-04-22U-44032026-02-10
N206111-00312527810*PED2033-10-22Pediatric extension
N206111-003102586372034-04-03U-22902019-04-30
N206111-003110903232034-04-03U-31932021-08-20
N206111-003116665902034-04-03U-41542025-03-28
N206111-003118331662034-04-03U-37762024-01-03
N206111-003118331662034-04-03U-37772024-01-03
N206111-003122631532034-04-03U-41542025-04-29
N206111-003124271622034-04-03U-42872025-10-29
N206111-003124339062034-04-03U-42932025-10-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N206111-001NPP2026-06-20
N206111-001PED2026-12-20
N206111-002NPP2026-06-20
N206111-002PED2026-12-20
N206111-003NPP2026-06-20
N206111-003PED2026-12-20
N206111-004NPP2026-06-20
N206111-004PED2026-12-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N206111-001SYNJARDY5MG;500MGTABLET / ORALRLD2015-08-26a50c72e98297…
2026-08-01 22:54:322026-06N206111-002SYNJARDY5MG;1GMTABLET / ORALRLD2015-08-26a50c72e98297…
2026-08-01 22:54:322026-06N206111-003SYNJARDY12.5MG;500MGTABLET / ORALRLD2015-08-26a50c72e98297…
2026-08-01 22:54:322026-06N206111-004SYNJARDY12.5MG;1GMTABLET / ORALRLD, RS2015-08-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N206111-00177139382027-04-15Drug substance, Drug product2015-09-30a50c72e98297…
2026-08-01 22:54:322026-06N206111-0017713938*PED2027-10-15Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00175794492028-08-01Drug substance2015-09-30a50c72e98297…
2026-08-01 22:54:322026-06N206111-0017579449*PED2029-02-01Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-001121151792030-02-11U-40232024-11-12a50c72e98297…
2026-08-01 22:54:322026-06N206111-00112115179*PED2030-08-11Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-001106104892030-09-30Drug product2020-05-01a50c72e98297…
2026-08-01 22:54:322026-06N206111-00110610489*PED2031-03-30Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-001125278102033-04-22U-44032026-02-10a50c72e98297…
2026-08-01 22:54:322026-06N206111-00112527810*PED2033-10-22Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-001102586372034-04-03U-22902019-04-30a50c72e98297…
2026-08-01 22:54:322026-06N206111-001110903232034-04-03U-31932021-08-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-001116665902034-04-03U-41542025-03-28a50c72e98297…
2026-08-01 22:54:322026-06N206111-001118132752034-04-03U-37592023-12-13a50c72e98297…
2026-08-01 22:54:322026-06N206111-001118331662034-04-03U-37762024-01-03a50c72e98297…
2026-08-01 22:54:322026-06N206111-001118331662034-04-03U-37772024-01-03a50c72e98297…
2026-08-01 22:54:322026-06N206111-001122631532034-04-03U-41542025-04-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-001124271622034-04-03U-42872025-10-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-001124339062034-04-03U-43042025-10-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-001124339062034-04-03U-42932025-10-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-001124339062034-04-03U-42942025-10-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-001124339062034-04-03U-42952025-10-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-001124339062034-04-03U-42962025-10-29a50c72e98297…
2026-08-01 22:54:322026-06N206111-00199499972034-05-17U-35322023-03-01a50c72e98297…
2026-08-01 22:54:322026-06N206111-00199499972034-05-17U-35332023-03-01a50c72e98297…
2026-08-01 22:54:322026-06N206111-00110258637*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00111090323*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00111813275*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00111833166*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00112433906*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-0019949997*PED2034-11-17Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00277139382027-04-15Drug substance, Drug product2015-09-30a50c72e98297…
2026-08-01 22:54:322026-06N206111-0027713938*PED2027-10-15Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-00275794492028-08-01Drug substance2015-09-30a50c72e98297…
2026-08-01 22:54:322026-06N206111-0027579449*PED2029-02-01Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-002121151792030-02-11U-40232024-11-12a50c72e98297…
2026-08-01 22:54:322026-06N206111-00212115179*PED2030-08-11Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-002106104892030-09-30Drug product2020-05-01a50c72e98297…
2026-08-01 22:54:322026-06N206111-00210610489*PED2031-03-30Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206111-002125278102033-04-22U-44032026-02-10a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N206111-001NPP2026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-001PED2026-12-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-002NPP2026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-002PED2026-12-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-003NPP2026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-003PED2026-12-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-004NPP2026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N206111-004PED2026-12-20a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SynjardyEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.0fdd0255-0055-65f3-b2c0-db8fbb87beae2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 206111
application number: NDA206111
ndc (product): 0597-0180
ndc (product): 0597-0168
ndc (product): 0597-0159
ndc (product): 0597-0175

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83952SUPPL 2025-10-28
83927SUPPL 2025-10-27
83925SUPPL 2025-10-27
81526SUPPL 2025-03-11
81510SUPPL 2025-03-11
76012SUPPL 2023-10-31
75999SUPPL 2023-10-31
74593SUPPL 2023-06-22
74590SUPPL 2023-06-22
74576SUPPL 2023-06-21
73453SUPPL 2023-02-10
73396SUPPL 2023-02-07
72376SUPPL2022-10-17
72375SUPPL2022-10-17
72339SUPPL2022-10-14
70633SUPPL2022-03-28
70632SUPPL2022-03-28
70582SUPPL2022-03-22
67804SUPPL2021-06-15
67803SUPPL2021-06-15
67796SUPPL2021-06-14
67795SUPPL2021-06-14
67794SUPPL2021-06-14
61674SUPPL2020-01-27
61662SUPPL2020-01-27
56177SUPPL2018-10-30
56162SUPPL2018-10-29
56161SUPPL2018-10-29
50713SUPPL2017-12-15
50691SUPPL2017-12-14
50688SUPPL2017-12-14
46665SUPPL2017-01-04
46664SUPPL2017-01-04
46663SUPPL2017-01-04
46558SUPPL2016-12-27
46545SUPPL2016-12-27
45357SUPPL2016-09-22
45356SUPPL2016-09-22
46077ORIG2016-08-04
32780SUPPL2016-07-12
40525SUPPL2015-12-08
32781SUPPL2015-12-07
40524ORIG2015-09-02
32779ORIG2015-09-02