Application 209806

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;500MG	Yes	No
002	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;1GM	Yes	No
003	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	7.5MG;500MG	Yes	No
004	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	7.5MG;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
N209806-001	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19
N209806-002	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19
N209806-003	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19
N209806-004	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209806-001	9308204	2030-10-21		Drug product	2018-01-16
N209806-001	9439902	2030-10-21	U-2214		2018-01-16
N209806-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209806-002	9308204	2030-10-21		Drug product	2018-01-16
N209806-002	9439902	2030-10-21	U-2214		2018-01-16
N209806-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209806-003	9308204	2030-10-21		Drug product	2018-01-16
N209806-003	9439902	2030-10-21	U-2214		2018-01-16
N209806-003	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16
N209806-004	9308204	2030-10-21		Drug product	2018-01-16
N209806-004	9439902	2030-10-21	U-2214		2018-01-16
N209806-004	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16

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	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-001	SEGLUROMET	2.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-002	SEGLUROMET	2.5MG;1GM	TABLET / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-003	SEGLUROMET	7.5MG;500MG	TABLET / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-004	SEGLUROMET	7.5MG;1GM	TABLET / ORAL	RLD, RS	2017-12-19	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 516 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	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-003	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	9308204	2030-10-21		Drug product	2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	9439902	2030-10-21	U-2214		2018-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209806-004	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-001	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-002	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-003	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	9308204	2030-10-21		Drug product	2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	9439902	2030-10-21	U-2214		2018-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209806-004	8080580	2031-12-19	U-2214	Drug substance, Drug product	2018-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209806-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-002	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-003	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	9308204	2030-10-21		Drug product	2018-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209806-004	9439902	2030-10-21	U-2214		2018-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	9308204	2030-10-21		Drug product	2018-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-001	9439902	2030-10-21	U-2214		2018-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209806-002	8080580	2030-07-13	U-2214	Drug substance, Drug product	2018-01-16	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-001	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-002	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-003	M-275	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209806-004	M-275	2024-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-001	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-002	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-003	M-275	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209806-004	M-275	2024-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-001	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-002	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-003	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209806-004	M-275	2024-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-001	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-002	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-003	M-275	2024-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209806-004	M-275	2024-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209806-001	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209806-002	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209806-003	M-275	2024-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209806-004	M-275	2024-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-001	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-002	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-003	M-275	2024-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209806-004	M-275	2024-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-001	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-002	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-003	M-275	2024-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209806-004	M-275	2024-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-001	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-002	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-003	M-275	2024-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209806-004	M-275	2024-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209806-001	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209806-002	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209806-003	M-275	2024-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209806-004	M-275	2024-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-001	NCE	2022-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-001	M-275	2024-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-002	NCE	2022-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209806-002	M-275	2024-09-17	`5c6f7cd8ea54…`

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
SEGLUROMET	ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	a6aeb99a-ce49-4125-90ce-642df3f1ebad	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209806 application number: NDA209806 ndc (product): 0006-5369 ndc (product): 0006-5370 ndc (product): 0006-5374 ndc (product): 0006-5373

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
50090-6217	SEGLUROMET	ertugliflozin and metformin hydrochloride	A-S Medication Solutions	NDA	Current
50090-6218	SEGLUROMET	ertugliflozin and metformin hydrochloride	A-S Medication Solutions	NDA	Current
50090-6231	SEGLUROMET	ertugliflozin and metformin hydrochloride	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80777	SUPPL	2024-12-30
80776	SUPPL	2024-12-30
80764	SUPPL	2024-12-27
75430	SUPPL	2023-09-13
75421	SUPPL	2023-09-13
72364	SUPPL	2022-10-17
72363	SUPPL	2022-10-17
72336	SUPPL	2022-10-14
70391	SUPPL	2022-03-03
70390	SUPPL	2022-03-03
70384	SUPPL	2022-03-03
68690	SUPPL	2021-09-21
68666	SUPPL	2021-09-20
68665	SUPPL	2021-09-20
61678	SUPPL	2020-01-27
61659	SUPPL	2020-01-27
61658	SUPPL	2020-01-27
56187	SUPPL	2018-10-30
56154	SUPPL	2018-10-29
56153	SUPPL	2018-10-29
52810	ORIG	2018-03-05
50887	ORIG	2017-12-27
50793	ORIG	2017-12-19