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 1.

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 · 51 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	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	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	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.

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
2026-08-01 22:54:32	2026-06	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N201281-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 51 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	N201281-001	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10973827	2029-04-02		Drug product	2021-05-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9415016	2029-04-02		Drug product	2016-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10022379*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10973827*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9415016*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9155705	2030-05-21		Drug product	2015-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8846695	2030-06-04	U-1503		2014-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9155705*PED	2030-11-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8846695*PED	2030-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	12364700*PED	2037-12-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10973827	2029-04-02		Drug product	2021-05-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9415016	2029-04-02		Drug product	2016-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10022379*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10973827*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9415016*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9155705	2030-05-21		Drug product	2015-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8846695	2030-06-04	U-1503		2014-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9155705*PED	2030-11-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8846695*PED	2030-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	12364700*PED	2037-12-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	10973827	2029-04-02		Drug product	2021-05-05	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N201281-001	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	PED	2026-12-20	`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
Jentadueto	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	2024-06-27	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

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