Application 208026

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JENTADUETO XR	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM	Yes	No
002	JENTADUETO XR	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208026-001	JENTADUETO XR	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-05-27
N208026-002	JENTADUETO XR	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 38 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208026-001	8883805	2025-11-26		Drug product	2016-06-22
N208026-001	8883805*PED	2026-05-26		Pediatric extension
N208026-001	8673927	2027-05-04	U-1503	Delist requested	2016-06-22
N208026-001	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22
N208026-001	8673927*PED	2027-11-04		Pediatric extension
N208026-001	9173859*PED	2027-11-04		Pediatric extension
N208026-001	10022379	2029-04-02	U-2339		2018-08-06
N208026-001	12678442	2029-04-02		Drug product	2026-08-10
N208026-001	9415016	2029-04-02		Drug product	2016-08-30
N208026-001	10022379*PED	2029-10-02		Pediatric extension
N208026-001	9415016*PED	2029-10-02		Pediatric extension
N208026-001	11911388	2030-04-10	U-3854		2024-03-25
N208026-001	9155705	2030-05-21		Drug product	2016-06-22
N208026-001	9155705*PED	2030-11-21		Pediatric extension
N208026-001	9555001	2033-03-06	U-1967	Drug product	2017-02-22
N208026-001	9555001	2033-03-06	U-1968	Drug product	2017-02-22
N208026-001	9555001*PED	2033-09-06		Pediatric extension
N208026-001	12364700	2037-06-08	U-4224		2025-07-31
N208026-001	12364700*PED	2037-12-08		Pediatric extension
N208026-002	8883805	2025-11-26		Drug product	2016-06-22
N208026-002	8883805*PED	2026-05-26		Pediatric extension
N208026-002	8673927	2027-05-04	U-1503	Delist requested	2016-06-22
N208026-002	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22
N208026-002	8673927*PED	2027-11-04		Pediatric extension
N208026-002	9173859*PED	2027-11-04		Pediatric extension
N208026-002	10022379	2029-04-02	U-2339		2018-08-06
N208026-002	12678442	2029-04-02		Drug product	2026-08-10
N208026-002	9415016	2029-04-02		Drug product	2016-08-30
N208026-002	10022379*PED	2029-10-02		Pediatric extension
N208026-002	9415016*PED	2029-10-02		Pediatric extension
N208026-002	11911388	2030-04-10	U-3854		2024-03-25
N208026-002	9155705	2030-05-21		Drug product	2016-06-22
N208026-002	9155705*PED	2030-11-21		Pediatric extension
N208026-002	9555001	2033-03-06	U-1967	Drug product	2017-02-22
N208026-002	9555001	2033-03-06	U-1968	Drug product	2017-02-22
N208026-002	9555001*PED	2033-09-06		Pediatric extension
N208026-002	12364700	2037-06-08	U-4224		2025-07-31
N208026-002	12364700*PED	2037-12-08		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208026-001	M-295	2026-06-20
N208026-001	PED	2026-12-20
N208026-002	M-295	2026-06-20
N208026-002	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 3 · 86 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	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-05-27	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,318 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	N208026-001	8883805	2025-11-26		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	8883805*PED	2026-05-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	8673927	2027-05-04	U-1503	Delist requested	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	8673927*PED	2027-11-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9173859*PED	2027-11-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	10022379	2029-04-02	U-2339		2018-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	12678442	2029-04-02		Drug product	2026-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9415016	2029-04-02		Drug product	2016-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	10022379*PED	2029-10-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9415016*PED	2029-10-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	11911388	2030-04-10	U-3854		2024-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9155705	2030-05-21		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9155705*PED	2030-11-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9555001	2033-03-06	U-1967	Drug product	2017-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9555001	2033-03-06	U-1968	Drug product	2017-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	9555001*PED	2033-09-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	12364700	2037-06-08	U-4224		2025-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	12364700*PED	2037-12-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	8883805	2025-11-26		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	8883805*PED	2026-05-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	8673927	2027-05-04	U-1503	Delist requested	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	8673927*PED	2027-11-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9173859*PED	2027-11-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	10022379	2029-04-02	U-2339		2018-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	12678442	2029-04-02		Drug product	2026-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9415016	2029-04-02		Drug product	2016-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	10022379*PED	2029-10-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9415016*PED	2029-10-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	11911388	2030-04-10	U-3854		2024-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9155705	2030-05-21		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9155705*PED	2030-11-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9555001	2033-03-06	U-1968	Drug product	2017-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9555001	2033-03-06	U-1967	Drug product	2017-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	9555001*PED	2033-09-06		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	12364700	2037-06-08	U-4224		2025-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	12364700*PED	2037-12-08		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208026-001	8883805	2025-11-26		Drug product	2016-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208026-001	8883805*PED	2026-05-26		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 156 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	N208026-001	M-295	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-001	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	M-295	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208026-002	PED	2026-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208026-001	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208026-001	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208026-002	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208026-002	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208026-001	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208026-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208026-002	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208026-002	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208026-001	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208026-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208026-002	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208026-002	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208026-001	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208026-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208026-002	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208026-002	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208026-001	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208026-001	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208026-002	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208026-002	PED	2026-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208026-001	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208026-001	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208026-002	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208026-002	PED	2026-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208026-001	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208026-001	PED	2026-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208026-002	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208026-002	PED	2026-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208026-001	M-295	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208026-001	PED	2026-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208026-002	M-295	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208026-002	PED	2026-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208026-001	M-295	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208026-001	PED	2026-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208026-002	M-295	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208026-002	PED	2026-12-20	`5bbf6a4d5a75…`

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
Jentadueto XR	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208026 application number: NDA208026 ndc (product): 0597-0275 ndc (product): 0597-0270

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0270	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0270	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0270	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0270	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0275	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0275	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0275	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0275	Jentadueto XR	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74602	SUPPL	2023-06-22
74601	SUPPL	2023-06-22
74574	SUPPL	2023-06-21
68875	SUPPL	2021-10-05
68855	SUPPL	2021-10-01
68854	SUPPL	2021-10-01
62387	SUPPL	2020-03-31
62386	SUPPL	2020-03-31
62377	SUPPL	2020-03-31
59965	SUPPL	2019-09-10
59259	SUPPL	2019-07-08
59258	SUPPL	2019-07-08
59252	SUPPL	2019-07-05
59221	SUPPL	2019-07-02
49410	SUPPL	2017-08-15
49343	SUPPL	2017-08-11
48819	ORIG	2017-06-23
48818	ORIG	2017-06-23
47616	SUPPL	2017-03-21
47606	SUPPL	2017-03-20
46554	SUPPL	2016-12-27
46541	SUPPL	2016-12-27
40612	ORIG	2016-06-01
32878	ORIG	2016-06-01