Application 022545

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	TABLET;ORAL	EQ 150MG BASE;EQ 5MG BASE	No	No
002	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	TABLET;ORAL	EQ 150MG BASE;EQ 10MG BASE	No	No
003	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	TABLET;ORAL	EQ 300MG BASE;EQ 5MG BASE	No	No
004	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	TABLET;ORAL	EQ 300MG BASE;EQ 10MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
N022545-001	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26
N022545-002	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26
N022545-003	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26
N022545-004	TEKAMLO	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
N022545-001	8613949	2029-12-21	Drug product
N022545-002	8613949	2029-12-21	Drug product
N022545-003	8613949	2029-12-21	Drug product
N022545-004	8613949	2029-12-21	Drug product

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022545-001	TEKAMLO	EQ 150MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022545-002	TEKAMLO	EQ 150MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022545-003	TEKAMLO	EQ 300MG BASE;EQ 5MG BASE	TABLET / ORAL	2010-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022545-004	TEKAMLO	EQ 300MG BASE;EQ 10MG BASE	TABLET / ORAL	2010-08-26	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-10-15 13:18:30	2026-09	N022545-001	8613949	2029-12-21	Drug product	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022545-002	8613949	2029-12-21	Drug product	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022545-003	8613949	2029-12-21	Drug product	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022545-004	8613949	2029-12-21	Drug product	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022545-001	8613949	2029-12-21	Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022545-002	8613949	2029-12-21	Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022545-003	8613949	2029-12-21	Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022545-004	8613949	2029-12-21	Drug product	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022545-001	8613949	2029-12-21	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022545-002	8613949	2029-12-21	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022545-003	8613949	2029-12-21	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022545-004	8613949	2029-12-21	Drug product	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022545-001	8613949	2029-12-21	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022545-002	8613949	2029-12-21	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022545-003	8613949	2029-12-21	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022545-004	8613949	2029-12-21	Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022545-001	8613949	2029-12-21	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022545-002	8613949	2029-12-21	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022545-003	8613949	2029-12-21	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022545-004	8613949	2029-12-21	Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022545-001	8613949	2029-12-21	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022545-002	8613949	2029-12-21	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022545-003	8613949	2029-12-21	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022545-004	8613949	2029-12-21	Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022545-001	8613949	2029-12-21	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022545-002	8613949	2029-12-21	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022545-003	8613949	2029-12-21	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022545-004	8613949	2029-12-21	Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022545-001	8613949	2029-12-21	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022545-002	8613949	2029-12-21	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022545-003	8613949	2029-12-21	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022545-004	8613949	2029-12-21	Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022545-001	8613949	2029-12-21	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022545-002	8613949	2029-12-21	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022545-003	8613949	2029-12-21	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022545-004	8613949	2029-12-21	Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022545-001	8613949	2029-12-21	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022545-002	8613949	2029-12-21	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022545-003	8613949	2029-12-21	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022545-004	8613949	2029-12-21	Drug product	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45850	SUPPL	2016-11-08
45829	SUPPL	2016-11-08
17701	SUPPL	2015-12-28
7524	SUPPL	2015-12-23
38833	SUPPL	2015-04-02
29851	SUPPL	2015-04-01
17700	SUPPL	2014-03-19
7523	SUPPL	2013-11-06
17699	SUPPL	2013-11-04
7522	SUPPL	2012-10-02
7520	SUPPL	2012-10-02
38832	SUPPL	2012-10-01
17698	SUPPL	2012-10-01
7521	SUPPL	2012-04-18
17697	SUPPL	2012-04-16
29848	SUPPL	2012-02-07
38831	SUPPL	2012-02-06
29850	SUPPL	2012-02-06
38830	SUPPL	2012-01-31
29849	SUPPL	2011-11-16
17696	SUPPL	2011-11-14
17695	SUPPL	2011-10-20
29847	SUPPL	2011-10-14
44776	ORIG	2011-05-25
22052	ORIG	2011-05-25
38829	SUPPL	2011-04-01
29846	SUPPL	2011-04-01
7519	ORIG	2010-08-31
17694	ORIG	2010-08-27