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 1.

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.

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	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`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	N201280-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

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	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	11033552	2027-05-04		Drug product	2021-07-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	12178819	2027-05-04		Drug product	2025-01-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	11033552*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	10034877	2029-08-05	U-2347		2018-08-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	9486526	2029-08-05	U-1915		2016-11-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	10034877*PED	2030-02-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	9486526*PED	2030-02-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8846695*PED	2030-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	8853156*PED	2031-09-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	12364700*PED	2037-12-08		Pediatric extension		`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	N201280-001	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201280-001	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 · 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

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