Application 212614

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG;1GM	Yes	No
002	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;5MG;1GM	Yes	No
003	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;2.5MG;1GM	Yes	No
004	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	25MG;5MG;1GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N212614-001	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27
N212614-002	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27
N212614-003	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27
N212614-004	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27

Orange Book patents#

Current patent rows page 1 of 2 · 111 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212614-001	8883805	2025-11-26		Drug product	2020-02-18
N212614-001	8883805*PED	2026-05-26		Pediatric extension
N212614-001	7713938	2027-04-15		Drug substance, Drug product	2020-02-18
N212614-001	7713938*PED	2027-10-15		Pediatric extension
N212614-001	7579449	2028-08-01		Drug substance	2020-02-18
N212614-001	7579449*PED	2029-02-01		Pediatric extension
N212614-001	10022379	2029-04-02	U-2732	Drug product	2020-02-18
N212614-001	9415016	2029-04-02		Drug product	2020-02-18
N212614-001	8551957	2029-10-14	U-2730	Drug product	2020-02-18
N212614-001	12115179	2030-02-11	U-4023		2024-11-12
N212614-001	8551957*PED	2030-04-14		Pediatric extension
N212614-001	9155705	2030-05-21		Drug product	2020-02-18
N212614-001	10406172	2030-06-15	U-2733	Drug product	2020-02-18
N212614-001	12115179*PED	2030-08-11		Pediatric extension
N212614-001	10596120	2032-03-07	U-2776	Drug product	2020-04-21
N212614-001	10596120	2032-03-07	U-2790	Drug product	2020-04-21
N212614-001	11564886	2032-03-07	U-3531	Drug product	2023-03-01
N212614-001	10258637	2034-04-03	U-2731		2020-02-18
N212614-001	11090323	2034-04-03	U-3192		2021-08-20
N212614-001	11833166	2034-04-03	U-3776		2024-01-03
N212614-001	11833166	2034-04-03	U-3777		2024-01-03
N212614-001	9949998	2034-06-11	U-2731		2020-02-18
N212614-001	10258637*PED	2034-10-03		Pediatric extension
N212614-001	11090323*PED	2034-10-03		Pediatric extension
N212614-001	11833166*PED	2034-10-03		Pediatric extension
N212614-001	9949998*PED	2034-12-11		Pediatric extension
N212614-001	12364700	2037-06-08	U-4224		2025-07-31
N212614-001	12364700*PED	2037-12-08		Pediatric extension
N212614-002	8883805	2025-11-26		Drug product	2020-02-18
N212614-002	8883805*PED	2026-05-26		Pediatric extension
N212614-002	7713938	2027-04-15		Drug substance, Drug product	2020-02-18
N212614-002	7713938*PED	2027-10-15		Pediatric extension
N212614-002	7579449	2028-08-01		Drug substance	2020-02-18
N212614-002	7579449*PED	2029-02-01		Pediatric extension
N212614-002	10022379	2029-04-02	U-2732	Drug product	2020-02-18
N212614-002	9415016	2029-04-02		Drug product	2020-02-18
N212614-002	8551957	2029-10-14	U-2730	Drug product	2020-02-18
N212614-002	12115179	2030-02-11	U-4023		2024-11-12
N212614-002	8551957*PED	2030-04-14		Pediatric extension
N212614-002	9155705	2030-05-21		Drug product	2020-02-18
N212614-002	10406172	2030-06-15	U-2733	Drug product	2020-02-18
N212614-002	12115179*PED	2030-08-11		Pediatric extension
N212614-002	10596120	2032-03-07	U-2776	Drug product	2020-04-21
N212614-002	10596120	2032-03-07	U-2790	Drug product	2020-04-21
N212614-002	11564886	2032-03-07	U-3531	Drug product	2023-03-01
N212614-002	10258637	2034-04-03	U-2731		2020-02-18
N212614-002	11090323	2034-04-03	U-3192		2021-08-20
N212614-002	11833166	2034-04-03	U-3776		2024-01-03
N212614-002	11833166	2034-04-03	U-3777		2024-01-03
N212614-002	9949998	2034-06-11	U-2731		2020-02-18
N212614-002	10258637*PED	2034-10-03		Pediatric extension
N212614-002	11090323*PED	2034-10-03		Pediatric extension
N212614-002	11833166*PED	2034-10-03		Pediatric extension
N212614-002	9949998*PED	2034-12-11		Pediatric extension
N212614-002	12364700	2037-06-08	U-4224		2025-07-31
N212614-002	12364700*PED	2037-12-08		Pediatric extension
N212614-003	8883805	2025-11-26		Drug product	2020-02-18
N212614-003	8883805*PED	2026-05-26		Pediatric extension
N212614-003	7713938	2027-04-15		Drug substance, Drug product	2020-02-18
N212614-003	7713938*PED	2027-10-15		Pediatric extension
N212614-003	7579449	2028-08-01		Drug substance	2020-02-18
N212614-003	7579449*PED	2029-02-01		Pediatric extension
N212614-003	10022379	2029-04-02	U-2732	Drug product	2020-02-18
N212614-003	9415016	2029-04-02		Drug product	2020-02-18
N212614-003	8551957	2029-10-14	U-2730	Drug product	2020-02-18
N212614-003	12115179	2030-02-11	U-4023		2024-11-12
N212614-003	8551957*PED	2030-04-14		Pediatric extension
N212614-003	9155705	2030-05-21		Drug product	2020-02-18
N212614-003	10406172	2030-06-15	U-2733	Drug product	2020-02-18
N212614-003	12115179*PED	2030-08-11		Pediatric extension
N212614-003	10596120	2032-03-07	U-2776	Drug product	2020-04-21
N212614-003	10596120	2032-03-07	U-2790	Drug product	2020-04-21
N212614-003	11564886	2032-03-07	U-3531	Drug product	2023-03-01
N212614-003	10258637	2034-04-03	U-2731		2020-02-18
N212614-003	11090323	2034-04-03	U-3192		2021-08-20
N212614-003	11833166	2034-04-03	U-3776		2024-01-03
N212614-003	11833166	2034-04-03	U-3777		2024-01-03
N212614-003	9949998	2034-06-11	U-2731		2020-02-18
N212614-003	10258637*PED	2034-10-03		Pediatric extension
N212614-003	11090323*PED	2034-10-03		Pediatric extension

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N212614-001	8883805	2025-11-26		Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	7713938	2027-04-15		Drug substance, Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	7713938*PED	2027-10-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	7579449	2028-08-01		Drug substance	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	7579449*PED	2029-02-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	10022379	2029-04-02	U-2732	Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	9415016	2029-04-02		Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	8551957	2029-10-14	U-2730	Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	12115179	2030-02-11	U-4023		2024-11-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	8551957*PED	2030-04-14		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	9155705	2030-05-21		Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	10406172	2030-06-15	U-2733	Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	12115179*PED	2030-08-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	10596120	2032-03-07	U-2790	Drug product	2020-04-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	10596120	2032-03-07	U-2776	Drug product	2020-04-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	11564886	2032-03-07	U-3531	Drug product	2023-03-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	10258637	2034-04-03	U-2731		2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	11090323	2034-04-03	U-3192		2021-08-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	11833166	2034-04-03	U-3776		2024-01-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	11833166	2034-04-03	U-3777		2024-01-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	9949998	2034-06-11	U-2731		2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	10258637*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	11090323*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	11833166*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	9949998*PED	2034-12-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-001	12364700*PED	2037-12-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	8883805	2025-11-26		Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	7713938	2027-04-15		Drug substance, Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	7713938*PED	2027-10-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	7579449	2028-08-01		Drug substance	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	7579449*PED	2029-02-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	10022379	2029-04-02	U-2732	Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	9415016	2029-04-02		Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	8551957	2029-10-14	U-2730	Drug product	2020-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	12115179	2030-02-11	U-4023		2024-11-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	8551957*PED	2030-04-14		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212614-002	9155705	2030-05-21		Drug product	2020-02-18	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Trijardy XR	EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	71873567-9594-452a-bb92-34a129adecac	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212614 application number: NDA212614 ndc (product): 0597-0380 ndc (product): 0597-0390 ndc (product): 0597-0395 ndc (product): 0597-0385

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83955	SUPPL	2025-10-28
83935	SUPPL	2025-10-27
83934	SUPPL	2025-10-27
76014	SUPPL	2023-10-31
76003	SUPPL	2023-10-31
72486	SUPPL	2022-10-28
72485	SUPPL	2022-10-28
72326	SUPPL	2022-10-14
67806	SUPPL	2021-06-15
67805	SUPPL	2021-06-15
67785	SUPPL	2021-06-14
67784	SUPPL	2021-06-14
67783	SUPPL	2021-06-14
65143	SUPPL	2020-11-03
65142	SUPPL	2020-11-03
65133	SUPPL	2020-11-03
64830	ORIG	2020-10-05
61705	ORIG	2020-01-28
61703	ORIG	2020-01-28
61702	ORIG	2020-01-28