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 43.

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 62 · 2,476 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	N208658-001	7713938	2027-04-15		Drug substance, Drug product	2017-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	7579449	2028-08-01		Drug substance	2017-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12115179	2030-02-11	U-4023		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12115179*PED	2030-08-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	10596120	2032-03-07	U-2775	Drug product	2020-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	10596120	2032-03-07	U-2792	Drug product	2020-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	10596120*PED	2032-09-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	10258637	2034-04-03	U-2290		2019-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11090323	2034-04-03	U-3193		2021-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11666590	2034-04-03	U-4154		2025-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11813275	2034-04-03	U-3759		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11833166	2034-04-03	U-3776		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11833166	2034-04-03	U-3777		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12263153	2034-04-03	U-4154		2025-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12427162	2034-04-03	U-4287		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12433906	2034-04-03	U-4304		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12433906	2034-04-03	U-4293		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12433906	2034-04-03	U-4294		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12433906	2034-04-03	U-4295		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12433906	2034-04-03	U-4296		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	9949997	2034-05-17	U-3532		2023-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	9949997	2034-05-17	U-3533		2023-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	9949998	2034-06-11	U-2290		2018-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	10258637*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11090323*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11813275*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	11833166*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	12433906*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	9949997*PED	2034-11-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	9949998*PED	2034-12-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	7713938	2027-04-15		Drug substance, Drug product	2017-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	7579449	2028-08-01		Drug substance	2017-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	12115179	2030-02-11	U-4023		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	12115179*PED	2030-08-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	10596120	2032-03-07	U-2775	Drug product	2020-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	10596120	2032-03-07	U-2792	Drug product	2020-04-20	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 208 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N208658-001	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-003	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-003	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-004	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-004	PED	2026-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208658-001	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-001	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-002	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-002	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-003	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-003	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-004	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-004	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208658-001	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-002	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-002	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-003	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-003	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-004	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-004	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-001	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-002	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-002	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-003	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-003	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-004	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-004	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208658-001	M-296	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-002	M-296	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-002	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-003	M-296	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-003	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-004	M-296	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-004	PED	2026-12-20	`6a471c1ec25d…`

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
Synjardy XR	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	2026-08-11	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

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 · 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