Application 208658

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	Yes	No
002	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	Yes	No
003	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;1GM	Yes	No
004	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	25MG;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	RLD / RS	Approval date
N208658-001	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09
N208658-002	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09
N208658-003	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09
N208658-004	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09

Orange Book patents#

Current patent rows page 1 of 2 · 124 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208658-001	7713938	2027-04-15		Drug substance, Drug product	2017-01-04
N208658-001	7713938*PED	2027-10-15		Pediatric extension
N208658-001	7579449	2028-08-01		Drug substance	2017-01-04
N208658-001	7579449*PED	2029-02-01		Pediatric extension
N208658-001	12115179	2030-02-11	U-4023		2024-11-12
N208658-001	12115179*PED	2030-08-11		Pediatric extension
N208658-001	10596120	2032-03-07	U-2775	Drug product	2020-04-20
N208658-001	10596120	2032-03-07	U-2792	Drug product	2020-04-20
N208658-001	10596120*PED	2032-09-07		Pediatric extension
N208658-001	10258637	2034-04-03	U-2290		2019-04-30
N208658-001	11090323	2034-04-03	U-3193		2021-08-20
N208658-001	11666590	2034-04-03	U-4154		2025-03-28
N208658-001	11813275	2034-04-03	U-3759		2023-12-13
N208658-001	11833166	2034-04-03	U-3776		2024-01-03
N208658-001	11833166	2034-04-03	U-3777		2024-01-03
N208658-001	12263153	2034-04-03	U-4154		2025-04-29
N208658-001	12427162	2034-04-03	U-4287		2025-10-29
N208658-001	12433906	2034-04-03	U-4293		2025-10-29
N208658-001	12433906	2034-04-03	U-4294		2025-10-29
N208658-001	12433906	2034-04-03	U-4295		2025-10-29
N208658-001	12433906	2034-04-03	U-4296		2025-10-29
N208658-001	12433906	2034-04-03	U-4304		2025-10-29
N208658-001	9949997	2034-05-17	U-3532		2023-03-01
N208658-001	9949997	2034-05-17	U-3533		2023-03-01
N208658-001	9949998	2034-06-11	U-2290		2018-05-16
N208658-001	10258637*PED	2034-10-03		Pediatric extension
N208658-001	11090323*PED	2034-10-03		Pediatric extension
N208658-001	11813275*PED	2034-10-03		Pediatric extension
N208658-001	11833166*PED	2034-10-03		Pediatric extension
N208658-001	12433906*PED	2034-10-03		Pediatric extension
N208658-001	9949997*PED	2034-11-17		Pediatric extension
N208658-001	9949998*PED	2034-12-11		Pediatric extension
N208658-002	7713938	2027-04-15		Drug substance, Drug product	2017-01-04
N208658-002	7713938*PED	2027-10-15		Pediatric extension
N208658-002	7579449	2028-08-01		Drug substance	2017-01-04
N208658-002	7579449*PED	2029-02-01		Pediatric extension
N208658-002	12115179	2030-02-11	U-4023		2024-11-12
N208658-002	12115179*PED	2030-08-11		Pediatric extension
N208658-002	10596120	2032-03-07	U-2775	Drug product	2020-04-20
N208658-002	10596120	2032-03-07	U-2792	Drug product	2020-04-20
N208658-002	10596120*PED	2032-09-07		Pediatric extension
N208658-002	10258637	2034-04-03	U-2290		2019-04-30
N208658-002	11090323	2034-04-03	U-3193		2021-08-20
N208658-002	11666590	2034-04-03	U-4154		2025-03-28
N208658-002	11813275	2034-04-03	U-3759		2023-12-13
N208658-002	11833166	2034-04-03	U-3776		2024-01-03
N208658-002	11833166	2034-04-03	U-3777		2024-01-03
N208658-002	12263153	2034-04-03	U-4154		2025-04-29
N208658-002	12427162	2034-04-03	U-4287		2025-10-29
N208658-002	12433906	2034-04-03	U-4293		2025-10-29
N208658-002	12433906	2034-04-03	U-4294		2025-10-29
N208658-002	12433906	2034-04-03	U-4295		2025-10-29
N208658-002	12433906	2034-04-03	U-4296		2025-10-29
N208658-002	12433906	2034-04-03	U-4304		2025-10-29
N208658-002	9949997	2034-05-17	U-3532		2023-03-01
N208658-002	9949997	2034-05-17	U-3533		2023-03-01
N208658-002	9949998	2034-06-11	U-2290		2018-05-16
N208658-002	10258637*PED	2034-10-03		Pediatric extension
N208658-002	11090323*PED	2034-10-03		Pediatric extension
N208658-002	11813275*PED	2034-10-03		Pediatric extension
N208658-002	11833166*PED	2034-10-03		Pediatric extension
N208658-002	12433906*PED	2034-10-03		Pediatric extension
N208658-002	9949997*PED	2034-11-17		Pediatric extension
N208658-002	9949998*PED	2034-12-11		Pediatric extension
N208658-003	7713938	2027-04-15		Drug substance, Drug product	2017-01-04
N208658-003	7713938*PED	2027-10-15		Pediatric extension
N208658-003	7579449	2028-08-01		Drug substance	2017-01-04
N208658-003	7579449*PED	2029-02-01		Pediatric extension
N208658-003	12115179	2030-02-11	U-4023		2024-11-12
N208658-003	12115179*PED	2030-08-11		Pediatric extension
N208658-003	10596120	2032-03-07	U-2775	Drug product	2020-04-20
N208658-003	10596120	2032-03-07	U-2792	Drug product	2020-04-20
N208658-003	10596120*PED	2032-09-07		Pediatric extension
N208658-003	10258637	2034-04-03	U-2290		2019-04-30
N208658-003	11090323	2034-04-03	U-3193		2021-08-20
N208658-003	11666590	2034-04-03	U-4154		2025-03-28
N208658-003	11833166	2034-04-03	U-3776		2024-01-03
N208658-003	11833166	2034-04-03	U-3777		2024-01-03
N208658-003	12263153	2034-04-03	U-4154		2025-04-29
N208658-003	12427162	2034-04-03	U-4287		2025-10-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208658-001	M-296	2026-06-20
N208658-001	PED	2026-12-20
N208658-002	M-296	2026-06-20
N208658-002	PED	2026-12-20
N208658-003	M-296	2026-06-20
N208658-003	PED	2026-12-20
N208658-004	M-296	2026-06-20
N208658-004	PED	2026-12-20

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 124 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	N208658-001	7713938	2027-04-15		Drug substance, Drug product	2017-01-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	7713938*PED	2027-10-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	7579449	2028-08-01		Drug substance	2017-01-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	7579449*PED	2029-02-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12115179	2030-02-11	U-4023		2024-11-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12115179*PED	2030-08-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	10596120	2032-03-07	U-2775	Drug product	2020-04-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	10596120	2032-03-07	U-2792	Drug product	2020-04-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	10596120*PED	2032-09-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	10258637	2034-04-03	U-2290		2019-04-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11090323	2034-04-03	U-3193		2021-08-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11666590	2034-04-03	U-4154		2025-03-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11813275	2034-04-03	U-3759		2023-12-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11833166	2034-04-03	U-3776		2024-01-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11833166	2034-04-03	U-3777		2024-01-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12263153	2034-04-03	U-4154		2025-04-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12427162	2034-04-03	U-4287		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12433906	2034-04-03	U-4304		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12433906	2034-04-03	U-4293		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12433906	2034-04-03	U-4294		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12433906	2034-04-03	U-4295		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12433906	2034-04-03	U-4296		2025-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	9949997	2034-05-17	U-3532		2023-03-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	9949997	2034-05-17	U-3533		2023-03-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	9949998	2034-06-11	U-2290		2018-05-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	10258637*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11090323*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11813275*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	11833166*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	12433906*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	9949997*PED	2034-11-17		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	9949998*PED	2034-12-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	7713938	2027-04-15		Drug substance, Drug product	2017-01-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	7713938*PED	2027-10-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	7579449	2028-08-01		Drug substance	2017-01-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	7579449*PED	2029-02-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	12115179	2030-02-11	U-4023		2024-11-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	12115179*PED	2030-08-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	10596120	2032-03-07	U-2775	Drug product	2020-04-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	10596120	2032-03-07	U-2792	Drug product	2020-04-20	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N208658-001	M-296	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-001	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	M-296	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-002	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-003	M-296	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-003	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-004	M-296	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208658-004	PED	2026-12-20	`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
Synjardy XR	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208658 application number: NDA208658 ndc (product): 0597-0300 ndc (product): 0597-0280 ndc (product): 0597-0290 ndc (product): 0597-0295

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
0597-0280	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0280	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0280	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0280	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0280	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0290	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0290	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0290	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0290	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0290	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0295	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0295	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0295	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0295	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0295	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0300	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0300	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0300	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0300	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0300	Synjardy	empagliflozin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83953	SUPPL	2025-10-28
83929	SUPPL	2025-10-27
83928	SUPPL	2025-10-27
81528	SUPPL	2025-03-11
81511	SUPPL	2025-03-11
76013	SUPPL	2023-10-31
76001	SUPPL	2023-10-31
74597	SUPPL	2023-06-22
74596	SUPPL	2023-06-22
74578	SUPPL	2023-06-21
74577	SUPPL	2023-06-21
73454	SUPPL	2023-02-10
73397	SUPPL	2023-02-07
72374	SUPPL	2022-10-17
72373	SUPPL	2022-10-17
72340	SUPPL	2022-10-14
70625	SUPPL	2022-03-28
70624	SUPPL	2022-03-28
70583	SUPPL	2022-03-22
67793	SUPPL	2021-06-14
67792	SUPPL	2021-06-14
67791	SUPPL	2021-06-14
67790	SUPPL	2021-06-14
67789	SUPPL	2021-06-14
61675	SUPPL	2020-01-27
61668	SUPPL	2020-01-27
61667	SUPPL	2020-01-27
56178	SUPPL	2018-10-30
56164	SUPPL	2018-10-29
56163	SUPPL	2018-10-29
50714	SUPPL	2017-12-15
50690	SUPPL	2017-12-14
50689	SUPPL	2017-12-14
50199	ORIG	2017-10-26
46555	SUPPL	2016-12-27
46542	SUPPL	2016-12-27
46166	ORIG	2016-12-15
46128	ORIG	2016-12-13