Application 201281

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;500MG	Yes	No
002	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;850MG	Yes	No
003	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;1GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201281-001	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30
N201281-002	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30
N201281-003	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N201281-001	AB
N201281-002	AB
N201281-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 54 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201281-001	8883805	2025-11-26		Drug product	2014-12-09
N201281-001	8883805*PED	2026-05-26		Pediatric extension
N201281-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201281-001	8673927*PED	2027-11-04		Pediatric extension
N201281-001	10022379	2029-04-02	U-2339		2018-08-06
N201281-001	10973827	2029-04-02		Drug product	2021-05-05
N201281-001	12678442	2029-04-02		Drug product	2026-08-10
N201281-001	9415016	2029-04-02		Drug product	2016-08-30
N201281-001	10022379*PED	2029-10-02		Pediatric extension
N201281-001	10973827*PED	2029-10-02		Pediatric extension
N201281-001	9415016*PED	2029-10-02		Pediatric extension
N201281-001	11911388	2030-04-10	U-3854		2024-03-25
N201281-001	9155705	2030-05-21		Drug product	2015-10-21
N201281-001	8846695	2030-06-04	U-1503		2014-10-21
N201281-001	9155705*PED	2030-11-21		Pediatric extension
N201281-001	8846695*PED	2030-12-04		Pediatric extension
N201281-001	12364700	2037-06-08	U-4224		2025-07-31
N201281-001	12364700*PED	2037-12-08		Pediatric extension
N201281-002	8883805	2025-11-26		Drug product	2014-12-09
N201281-002	8883805*PED	2026-05-26		Pediatric extension
N201281-002	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201281-002	8673927*PED	2027-11-04		Pediatric extension
N201281-002	10022379	2029-04-02	U-2339		2018-08-06
N201281-002	10973827	2029-04-02		Drug product	2021-05-05
N201281-002	12678442	2029-04-02		Drug product	2026-08-10
N201281-002	9415016	2029-04-02		Drug product	2016-08-30
N201281-002	10022379*PED	2029-10-02		Pediatric extension
N201281-002	10973827*PED	2029-10-02		Pediatric extension
N201281-002	9415016*PED	2029-10-02		Pediatric extension
N201281-002	11911388	2030-04-10	U-3854		2024-03-25
N201281-002	9155705	2030-05-21		Drug product	2015-10-21
N201281-002	8846695	2030-06-04	U-1503		2014-10-21
N201281-002	9155705*PED	2030-11-21		Pediatric extension
N201281-002	8846695*PED	2030-12-04		Pediatric extension
N201281-002	12364700	2037-06-08	U-4224		2025-07-31
N201281-002	12364700*PED	2037-12-08		Pediatric extension
N201281-003	8883805	2025-11-26		Drug product	2014-12-09
N201281-003	8883805*PED	2026-05-26		Pediatric extension
N201281-003	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201281-003	8673927*PED	2027-11-04		Pediatric extension
N201281-003	10022379	2029-04-02	U-2339		2018-08-06
N201281-003	10973827	2029-04-02		Drug product	2021-05-05
N201281-003	12678442	2029-04-02		Drug product	2026-08-10
N201281-003	9415016	2029-04-02		Drug product	2016-08-30
N201281-003	10022379*PED	2029-10-02		Pediatric extension
N201281-003	10973827*PED	2029-10-02		Pediatric extension
N201281-003	9415016*PED	2029-10-02		Pediatric extension
N201281-003	11911388	2030-04-10	U-3854		2024-03-25
N201281-003	9155705	2030-05-21		Drug product	2015-10-21
N201281-003	8846695	2030-06-04	U-1503	Delist requested	2014-10-21
N201281-003	9155705*PED	2030-11-21		Pediatric extension
N201281-003	8846695*PED	2030-12-04		Pediatric extension
N201281-003	12364700	2037-06-08	U-4224		2025-07-31
N201281-003	12364700*PED	2037-12-08		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N201281-001	M-295	2026-06-20
N201281-001	PED	2026-12-20
N201281-002	M-295	2026-06-20
N201281-002	PED	2026-12-20
N201281-003	M-295	2026-06-20
N201281-003	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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N201281-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201281-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201281-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201281-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201281-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-001	AB	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,872 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N201281-001	8883805	2025-11-26		Drug product	2014-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	8883805*PED	2026-05-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	8673927*PED	2027-11-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	10022379	2029-04-02	U-2339		2018-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	10973827	2029-04-02		Drug product	2021-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	12678442	2029-04-02		Drug product	2026-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	9415016	2029-04-02		Drug product	2016-08-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	10022379*PED	2029-10-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	10973827*PED	2029-10-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	9415016*PED	2029-10-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	11911388	2030-04-10	U-3854		2024-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	9155705	2030-05-21		Drug product	2015-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	8846695	2030-06-04	U-1503		2014-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	9155705*PED	2030-11-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	8846695*PED	2030-12-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	12364700	2037-06-08	U-4224		2025-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	12364700*PED	2037-12-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	8883805	2025-11-26		Drug product	2014-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	8883805*PED	2026-05-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	8673927*PED	2027-11-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	10022379	2029-04-02	U-2339		2018-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	10973827	2029-04-02		Drug product	2021-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	12678442	2029-04-02		Drug product	2026-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	9415016	2029-04-02		Drug product	2016-08-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	10022379*PED	2029-10-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	10973827*PED	2029-10-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	9415016*PED	2029-10-02		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	11911388	2030-04-10	U-3854		2024-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	9155705	2030-05-21		Drug product	2015-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	8846695	2030-06-04	U-1503		2014-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	9155705*PED	2030-11-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	8846695*PED	2030-12-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	12364700	2037-06-08	U-4224		2025-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	12364700*PED	2037-12-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	8883805	2025-11-26		Drug product	2014-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	8883805*PED	2026-05-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	8673927*PED	2027-11-04		Pediatric extension		`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N201281-001	M-295	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-001	PED	2026-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	M-295	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-002	PED	2026-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	M-295	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201281-003	PED	2026-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201281-001	M-295	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-001	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-002	M-295	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-002	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-003	M-295	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201281-003	PED	2026-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201281-001	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-001	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-002	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-002	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-003	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201281-003	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201281-001	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201281-001	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	PED	2026-12-20	`fd3edfee7708…`

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	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201281 application number: NDA201281 ndc (product): 0597-0147 ndc (product): 0597-0146 ndc (product): 0597-0148

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0146	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0146	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0146	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0146	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0147	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0147	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0147	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0147	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0148	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0148	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0148	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0148	Jentadueto	linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
63629-6524	Jentadueto	linagliptin and metformin hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-6524	Jentadueto	linagliptin and metformin hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74600	SUPPL	2023-06-22
74599	SUPPL	2023-06-22
74573	SUPPL	2023-06-21
70787	SUPPL	2022-04-18
70786	SUPPL	2022-04-18
70781	SUPPL	2022-04-18
62391	SUPPL	2020-03-31
62390	SUPPL	2020-03-31
62375	SUPPL	2020-03-31
59962	SUPPL	2019-09-10
59263	SUPPL	2019-07-08
59262	SUPPL	2019-07-08
59250	SUPPL	2019-07-05
59218	SUPPL	2019-07-02
49409	SUPPL	2017-08-15
49345	SUPPL	2017-08-11
47611	SUPPL	2017-03-21
47604	SUPPL	2017-03-20
46544	SUPPL	2016-12-27
46543	SUPPL	2016-12-27
46539	SUPPL	2016-12-27
46538	SUPPL	2016-12-27
40063	SUPPL	2015-09-03
32101	SUPPL	2015-09-01
19008	SUPPL	2015-07-30
32100	SUPPL	2015-07-29
32099	SUPPL	2014-07-31
19007	SUPPL	2014-07-31
40062	SUPPL	2014-05-28
9881	SUPPL	2014-05-23
32098	SUPPL	2013-09-10
19006	SUPPL	2013-09-09
24391	ORIG	2013-07-26
22849	ORIG	2013-07-26
40061	SUPPL	2013-06-25
32097	SUPPL	2013-06-20
9880	SUPPL	2012-09-27
32096	ORIG	2012-02-02
19005	ORIG	2012-02-01