Application 022401

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;40MG	Yes	No
002	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 10MG BASE;40MG	Yes	No
003	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;80MG	Yes	No
004	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 10MG BASE;80MG	Yes	Yes

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

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
N022401-001	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16
N022401-002	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16
N022401-003	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16
N022401-004	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022401-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022401-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022401-004	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022401-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022401-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022401-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022401-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022401-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022401-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022401-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022401-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022401-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022401-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022401-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022401-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022401-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022401-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022401-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022401-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022401-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022401-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022401-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022401-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022401-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022401-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022401-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022401-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022401-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022401-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022401-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022401-004	AB	1	`ea99ee380514…`

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0124	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0124	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0125	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0125	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0126	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0126	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0127	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0127	Twynsta	telmisartan/amlodipine	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52300	SUPPL	2018-02-02
52260	SUPPL	2018-02-02
38660	SUPPL	2016-01-25
7330	SUPPL	2016-01-15
17320	SUPPL	2014-12-16
7329	SUPPL	2014-12-15
29682	SUPPL	2012-11-16
38659	SUPPL	2012-11-15
29681	SUPPL	2012-10-23
7326	SUPPL	2012-10-23
17317	SUPPL	2012-10-22
17316	SUPPL	2012-10-22
7328	SUPPL	2012-04-02
17319	SUPPL	2012-03-30
29680	SUPPL	2012-01-23
17315	SUPPL	2012-01-23
7327	SUPPL	2011-11-16
17318	SUPPL	2011-11-14
7325	SUPPL	2011-06-07
38658	SUPPL	2011-06-06
38657	SUPPL	2010-07-31
29679	SUPPL	2010-07-29
42507	ORIG	2010-03-31
24295	ORIG	2010-03-31
29678	ORIG	2009-11-02
17314	ORIG	2009-10-16