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 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
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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206111-001	7713938	2027-04-15		Drug substance, Drug product	2015-09-30
N206111-001	7713938*PED	2027-10-15		Pediatric extension
N206111-001	7579449	2028-08-01		Drug substance	2015-09-30
N206111-001	7579449*PED	2029-02-01		Pediatric extension
N206111-001	12115179	2030-02-11	U-4023		2024-11-12
N206111-001	12115179*PED	2030-08-11		Pediatric extension
N206111-001	10610489	2030-09-30		Drug product	2020-05-01
N206111-001	10610489*PED	2031-03-30		Pediatric extension
N206111-001	12527810	2033-04-22	U-4403		2026-02-10
N206111-001	12527810*PED	2033-10-22		Pediatric extension
N206111-001	10258637	2034-04-03	U-2290		2019-04-30
N206111-001	11090323	2034-04-03	U-3193		2021-08-20
N206111-001	11666590	2034-04-03	U-4154		2025-03-28
N206111-001	11813275	2034-04-03	U-3759		2023-12-13
N206111-001	11833166	2034-04-03	U-3776		2024-01-03
N206111-001	11833166	2034-04-03	U-3777		2024-01-03
N206111-001	12263153	2034-04-03	U-4154		2025-04-29
N206111-001	12427162	2034-04-03	U-4287		2025-10-29
N206111-001	12433906	2034-04-03	U-4293		2025-10-29
N206111-001	12433906	2034-04-03	U-4294		2025-10-29
N206111-001	12433906	2034-04-03	U-4295		2025-10-29
N206111-001	12433906	2034-04-03	U-4296		2025-10-29
N206111-001	12433906	2034-04-03	U-4304		2025-10-29
N206111-001	9949997	2034-05-17	U-3532		2023-03-01
N206111-001	9949997	2034-05-17	U-3533		2023-03-01
N206111-001	10258637*PED	2034-10-03		Pediatric extension
N206111-001	11090323*PED	2034-10-03		Pediatric extension
N206111-001	11813275*PED	2034-10-03		Pediatric extension
N206111-001	11833166*PED	2034-10-03		Pediatric extension
N206111-001	12433906*PED	2034-10-03		Pediatric extension
N206111-001	9949997*PED	2034-11-17		Pediatric extension
N206111-002	7713938	2027-04-15		Drug substance, Drug product	2015-09-30
N206111-002	7713938*PED	2027-10-15		Pediatric extension
N206111-002	7579449	2028-08-01		Drug substance	2015-09-30
N206111-002	7579449*PED	2029-02-01		Pediatric extension
N206111-002	12115179	2030-02-11	U-4023		2024-11-12
N206111-002	12115179*PED	2030-08-11		Pediatric extension
N206111-002	10610489	2030-09-30		Drug product	2020-05-01
N206111-002	10610489*PED	2031-03-30		Pediatric extension
N206111-002	12527810	2033-04-22	U-4403		2026-02-10
N206111-002	12527810*PED	2033-10-22		Pediatric extension
N206111-002	10258637	2034-04-03	U-2290		2019-04-30
N206111-002	11090323	2034-04-03	U-3193		2021-08-20
N206111-002	11666590	2034-04-03	U-4154		2025-03-28
N206111-002	11813275	2034-04-03	U-3759		2023-12-13
N206111-002	11833166	2034-04-03	U-3776		2024-01-03
N206111-002	11833166	2034-04-03	U-3777		2024-01-03
N206111-002	12263153	2034-04-03	U-4154		2025-04-29
N206111-002	12427162	2034-04-03	U-4287		2025-10-29
N206111-002	12433906	2034-04-03	U-4293		2025-10-29
N206111-002	12433906	2034-04-03	U-4294		2025-10-29
N206111-002	12433906	2034-04-03	U-4295		2025-10-29
N206111-002	12433906	2034-04-03	U-4296		2025-10-29
N206111-002	12433906	2034-04-03	U-4304		2025-10-29
N206111-002	9949997	2034-05-17	U-3532		2023-03-01
N206111-002	9949997	2034-05-17	U-3533		2023-03-01
N206111-002	10258637*PED	2034-10-03		Pediatric extension
N206111-002	11090323*PED	2034-10-03		Pediatric extension
N206111-002	11813275*PED	2034-10-03		Pediatric extension
N206111-002	11833166*PED	2034-10-03		Pediatric extension
N206111-002	12433906*PED	2034-10-03		Pediatric extension
N206111-002	9949997*PED	2034-11-17		Pediatric extension
N206111-003	7713938	2027-04-15		Drug substance, Drug product	2015-09-30
N206111-003	7713938*PED	2027-10-15		Pediatric extension
N206111-003	7579449	2028-08-01		Drug substance	2015-09-30
N206111-003	7579449*PED	2029-02-01		Pediatric extension
N206111-003	12115179	2030-02-11	U-4023		2024-11-12
N206111-003	12115179*PED	2030-08-11		Pediatric extension
N206111-003	10610489	2030-09-30		Drug product	2020-05-01
N206111-003	10610489*PED	2031-03-30		Pediatric extension
N206111-003	12527810	2033-04-22	U-4403		2026-02-10
N206111-003	12527810*PED	2033-10-22		Pediatric extension
N206111-003	10258637	2034-04-03	U-2290		2019-04-30
N206111-003	11090323	2034-04-03	U-3193		2021-08-20
N206111-003	11666590	2034-04-03	U-4154		2025-03-28
N206111-003	11833166	2034-04-03	U-3776		2024-01-03
N206111-003	11833166	2034-04-03	U-3777		2024-01-03
N206111-003	12263153	2034-04-03	U-4154		2025-04-29
N206111-003	12427162	2034-04-03	U-4287		2025-10-29
N206111-003	12433906	2034-04-03	U-4293		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
N206111-001	NPP	2026-06-20
N206111-001	PED	2026-12-20
N206111-002	NPP	2026-06-20
N206111-002	PED	2026-12-20
N206111-003	NPP	2026-06-20
N206111-003	PED	2026-12-20
N206111-004	NPP	2026-06-20
N206111-004	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	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206111-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N206111-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N206111-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N206111-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206111-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N206111-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N206111-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N206111-004	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 52 · 2,056 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	N206111-001	7713938	2027-04-15		Drug substance, Drug product	2015-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	7579449	2028-08-01		Drug substance	2015-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12115179	2030-02-11	U-4023		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12115179*PED	2030-08-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	10610489	2030-09-30		Drug product	2020-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	10610489*PED	2031-03-30		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12527810	2033-04-22	U-4403		2026-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12527810*PED	2033-10-22		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	10258637	2034-04-03	U-2290		2019-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11090323	2034-04-03	U-3193		2021-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11666590	2034-04-03	U-4154		2025-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11813275	2034-04-03	U-3759		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11833166	2034-04-03	U-3776		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11833166	2034-04-03	U-3777		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12263153	2034-04-03	U-4154		2025-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12427162	2034-04-03	U-4287		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12433906	2034-04-03	U-4304		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12433906	2034-04-03	U-4293		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12433906	2034-04-03	U-4294		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12433906	2034-04-03	U-4295		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12433906	2034-04-03	U-4296		2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	9949997	2034-05-17	U-3532		2023-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	9949997	2034-05-17	U-3533		2023-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	10258637*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11090323*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11813275*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	11833166*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	12433906*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	9949997*PED	2034-11-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	7713938	2027-04-15		Drug substance, Drug product	2015-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	7579449	2028-08-01		Drug substance	2015-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	12115179	2030-02-11	U-4023		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	12115179*PED	2030-08-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	10610489	2030-09-30		Drug product	2020-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	10610489*PED	2031-03-30		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	12527810	2033-04-22	U-4403		2026-02-10	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 224 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	N206111-001	NPP	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-001	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	NPP	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-002	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-003	NPP	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-003	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-004	NPP	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206111-004	PED	2026-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206111-001	NPP	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-001	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-002	NPP	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-002	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-003	NPP	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-003	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-004	NPP	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206111-004	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206111-001	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-003	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-003	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-004	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-004	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-001	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-002	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-002	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-003	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-003	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-004	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-004	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206111-001	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-002	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-002	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-003	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-003	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-004	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-004	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	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	0fdd0255-0055-65f3-b2c0-db8fbb87beae	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206111 application number: NDA206111 ndc (product): 0597-0180 ndc (product): 0597-0168 ndc (product): 0597-0159 ndc (product): 0597-0175

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
0597-0159	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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83952	SUPPL	2025-10-28
83927	SUPPL	2025-10-27
83925	SUPPL	2025-10-27
81526	SUPPL	2025-03-11
81510	SUPPL	2025-03-11
76012	SUPPL	2023-10-31
75999	SUPPL	2023-10-31
74593	SUPPL	2023-06-22
74590	SUPPL	2023-06-22
74576	SUPPL	2023-06-21
73453	SUPPL	2023-02-10
73396	SUPPL	2023-02-07
72376	SUPPL	2022-10-17
72375	SUPPL	2022-10-17
72339	SUPPL	2022-10-14
70633	SUPPL	2022-03-28
70632	SUPPL	2022-03-28
70582	SUPPL	2022-03-22
67804	SUPPL	2021-06-15
67803	SUPPL	2021-06-15
67796	SUPPL	2021-06-14
67795	SUPPL	2021-06-14
67794	SUPPL	2021-06-14
61674	SUPPL	2020-01-27
61662	SUPPL	2020-01-27
56177	SUPPL	2018-10-30
56162	SUPPL	2018-10-29
56161	SUPPL	2018-10-29
50713	SUPPL	2017-12-15
50691	SUPPL	2017-12-14
50688	SUPPL	2017-12-14
46665	SUPPL	2017-01-04
46664	SUPPL	2017-01-04
46663	SUPPL	2017-01-04
46558	SUPPL	2016-12-27
46545	SUPPL	2016-12-27
45357	SUPPL	2016-09-22
45356	SUPPL	2016-09-22
46077	ORIG	2016-08-04
32780	SUPPL	2016-07-12
40525	SUPPL	2015-12-08
32781	SUPPL	2015-12-07
40524	ORIG	2015-09-02
32779	ORIG	2015-09-02