Application 201280

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRADJENTA	LINAGLIPTIN	TABLET;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201280-001	TRADJENTA	LINAGLIPTIN	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201280-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201280-001	8883805	2025-11-26		Drug product	2014-12-09
N201280-001	8883805*PED	2026-05-26		Pediatric extension
N201280-001	11033552	2027-05-04		Drug product	2021-07-09
N201280-001	12178819	2027-05-04		Drug product	2025-01-24
N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201280-001	11033552*PED	2027-11-04		Pediatric extension
N201280-001	8673927*PED	2027-11-04		Pediatric extension
N201280-001	10034877	2029-08-05	U-2347		2018-08-10
N201280-001	9486526	2029-08-05	U-1915		2016-11-18
N201280-001	10034877*PED	2030-02-05		Pediatric extension
N201280-001	9486526*PED	2030-02-05		Pediatric extension
N201280-001	11911388	2030-04-10	U-3854		2024-03-25
N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21
N201280-001	8846695*PED	2030-12-04		Pediatric extension
N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23
N201280-001	8853156*PED	2031-09-05		Pediatric extension
N201280-001	12364700	2037-06-08	U-4224		2025-07-31
N201280-001	12364700*PED	2037-12-08		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N201280-001	M-295	2026-06-20
N201280-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N201280-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201280-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201280-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201280-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201280-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201280-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201280-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201280-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201280-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201280-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201280-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201280-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201280-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201280-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201280-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201280-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201280-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201280-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201280-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201280-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201280-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201280-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201280-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 724 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	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	11033552	2027-05-04		Drug product	2021-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	12178819	2027-05-04		Drug product	2025-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	11033552*PED	2027-11-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8673927*PED	2027-11-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	10034877	2029-08-05	U-2347		2018-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	9486526	2029-08-05	U-1915		2016-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	10034877*PED	2030-02-05		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	9486526*PED	2030-02-05		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	11911388	2030-04-10	U-3854		2024-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8846695*PED	2030-12-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	8853156*PED	2031-09-05		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	12364700	2037-06-08	U-4224		2025-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	12364700*PED	2037-12-08		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	11033552	2027-05-04		Drug product	2021-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	12178819	2027-05-04		Drug product	2025-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	11033552*PED	2027-11-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8673927*PED	2027-11-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	10034877	2029-08-05	U-2347		2018-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	9486526	2029-08-05	U-1915		2016-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	10034877*PED	2030-02-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	9486526*PED	2030-02-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	11911388	2030-04-10	U-3854		2024-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8846695*PED	2030-12-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8853156*PED	2031-09-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	12364700	2037-06-08	U-4224		2025-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	12364700*PED	2037-12-08		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	11033552	2027-05-04		Drug product	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	12178819	2027-05-04		Drug product	2025-01-24	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 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	N201280-001	M-295	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201280-001	PED	2026-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201280-001	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201280-001	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201280-001	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	PED	2026-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	PED	2026-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	PED	2026-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	M-295	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	PED	2026-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	M-295	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	PED	2026-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	M-295	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	PED	2026-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201280-001	M-295	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201280-001	PED	2026-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	M-295	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	PED	2026-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	M-295	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	PED	2026-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	M-295	2026-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	PED	2026-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201280-001	M-295	2026-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201280-001	PED	2026-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	M-258	2022-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	M-252	2023-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201280-001	M-258	2022-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201280-001	M-252	2023-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201280-001	M-258	2022-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201280-001	M-252	2023-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201280-001	M-258	2022-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201280-001	M-252	2023-03-30	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tradjenta	LINAGLIPTIN	Cardinal Health 107, LLC	dfe327e8-f6ab-41e5-bdef-d520118cd83a	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201280 application number: NDA201280 ndc (product): 55154-0410
Tradjenta	LINAGLIPTIN	Boehringer Ingelheim Pharmaceuticals, Inc.	c797ea5c-cab7-494b-9044-27eba0cfe40f	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201280 application number: NDA201280 ndc (product): 0597-0140
Tradjenta	LINAGLIPTIN	A-S Medication Solutions	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201280 application number: NDA201280 ndc (product): 50090-4383

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0140	Tradjenta	linagliptin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0140	Tradjenta	linagliptin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0140	Tradjenta	linagliptin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0140	Tradjenta	linagliptin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0140	Tradjenta	linagliptin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
50090-4383	Tradjenta	linagliptin	A-S Medication Solutions	NDA	Current
50090-4383	Tradjenta	linagliptin	A-S Medication Solutions	NDA	Current
55154-0410	Tradjenta	linagliptin	Cardinal Health 107, LLC	NDA	Current
55154-0410	Tradjenta	linagliptin	Cardinal Health	NDA	Current
55154-0410	Tradjenta	linagliptin	Cardinal Health	NDA	Current
55154-0410	Tradjenta	linagliptin	Cardinal Health	NDA	Current
55154-0410	Tradjenta	linagliptin	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74595	SUPPL	2023-06-22
74594	SUPPL	2023-06-22
74572	SUPPL	2023-06-21
70784	SUPPL	2022-04-18
70783	SUPPL	2022-04-18
70780	SUPPL	2022-04-18
62393	SUPPL	2020-03-31
62392	SUPPL	2020-03-31
62374	SUPPL	2020-03-31
59963	SUPPL	2019-09-10
59265	SUPPL	2019-07-08
59264	SUPPL	2019-07-08
59249	SUPPL	2019-07-05
59217	SUPPL	2019-07-02
49408	SUPPL	2017-08-15
49347	SUPPL	2017-08-11
47609	SUPPL	2017-03-21
47603	SUPPL	2017-03-20
46618	SUPPL	2016-12-30
46553	SUPPL	2016-12-27
40060	SUPPL	2015-09-04
9879	SUPPL	2015-09-01
19004	SUPPL	2015-07-30
32095	SUPPL	2015-07-29
43362	SUPPL	2014-07-07
40059	SUPPL	2014-05-28
9878	SUPPL	2014-05-23
19003	SUPPL	2013-06-25
9877	SUPPL	2013-06-20
9876	SUPPL	2012-10-02
19002	SUPPL	2012-10-01
40058	SUPPL	2012-08-15
32094	SUPPL	2012-08-15
19001	SUPPL	2012-08-15
9875	SUPPL	2012-08-15
32093	SUPPL	2012-05-24
19000	SUPPL	2012-05-23
43361	ORIG	2011-06-07
24390	ORIG	2011-06-07
32092	ORIG	2011-05-06
18999	ORIG	2011-05-06