Application 200045

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 150MG BASE;EQ 5MG BASE;12.5MG	No	No
002	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 300MG BASE;EQ 5MG BASE;12.5MG	No	No
003	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 300MG BASE;EQ 5MG BASE;25MG	No	No
004	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 300MG BASE;EQ 10MG BASE;12.5MG	No	No
005	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 300MG BASE;EQ 10MG BASE;25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N200045-001	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	EQ 150MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21
N200045-002	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21
N200045-003	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;EQ 5MG BASE;25MG	TABLET / ORAL	2010-12-21
N200045-004	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;EQ 10MG BASE;12.5MG	TABLET / ORAL	2010-12-21
N200045-005	AMTURNIDE	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;EQ 10MG BASE;25MG	TABLET / ORAL	2010-12-21

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 6 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N200045-001	AMTURNIDE	EQ 150MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N200045-002	AMTURNIDE	EQ 300MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N200045-003	AMTURNIDE	EQ 300MG BASE;EQ 5MG BASE;25MG	TABLET / ORAL	2010-12-21	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N200045-004	AMTURNIDE	EQ 300MG BASE;EQ 10MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N200045-005	AMTURNIDE	EQ 300MG BASE;EQ 10MG BASE;25MG	TABLET / ORAL	2010-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200045-001	AMTURNIDE	EQ 150MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200045-002	AMTURNIDE	EQ 300MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200045-003	AMTURNIDE	EQ 300MG BASE;EQ 5MG BASE;25MG	TABLET / ORAL	2010-12-21	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200045-004	AMTURNIDE	EQ 300MG BASE;EQ 10MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200045-005	AMTURNIDE	EQ 300MG BASE;EQ 10MG BASE;25MG	TABLET / ORAL	2010-12-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200045-001	AMTURNIDE	EQ 150MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200045-002	AMTURNIDE	EQ 300MG BASE;EQ 5MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200045-003	AMTURNIDE	EQ 300MG BASE;EQ 5MG BASE;25MG	TABLET / ORAL	2010-12-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200045-004	AMTURNIDE	EQ 300MG BASE;EQ 10MG BASE;12.5MG	TABLET / ORAL	2010-12-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200045-005	AMTURNIDE	EQ 300MG BASE;EQ 10MG BASE;25MG	TABLET / ORAL	2010-12-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200045-001	8183295	2023-05-16	Drug product	2013-01-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200045-002	8183295	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200045-003	8183295	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200045-004	8183295	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200045-005	8183295	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200045-001	8183295	2023-05-16	Drug product	2013-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200045-002	8183295	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200045-003	8183295	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200045-004	8183295	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200045-005	8183295	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200045-001	8183295	2023-05-16	Drug product	2013-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200045-002	8183295	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200045-003	8183295	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200045-004	8183295	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200045-005	8183295	2023-05-16	Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200045-001	8618174	2021-11-15	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-001	8183295	2023-05-16	Drug product	2013-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-002	8618174	2021-11-15	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-002	8183295	2023-05-16	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-003	8618174	2021-11-15	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-003	8183295	2023-05-16	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-004	8618174	2021-11-15	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-004	8183295	2023-05-16	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-005	8618174	2021-11-15	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200045-005	8183295	2023-05-16	Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200045-001	8183295	2023-05-16	Drug product	2013-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200045-002	8183295	2023-05-16	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200045-003	8183295	2023-05-16	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200045-004	8183295	2023-05-16	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200045-005	8183295	2023-05-16	Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200045-001	8618174	2021-11-15	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-001	8183295	2023-05-16	Drug product	2013-01-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-002	8618174	2021-11-15	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-002	8183295	2023-05-16	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-003	8618174	2021-11-15	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-003	8183295	2023-05-16	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-004	8618174	2021-11-15	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-004	8183295	2023-05-16	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-005	8618174	2021-11-15	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200045-005	8183295	2023-05-16	Drug product		`782e0a99824c…`

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
45852	SUPPL	2016-11-08
45827	SUPPL	2016-11-08
18945	SUPPL	2015-12-28
9795	SUPPL	2015-12-23
18944	SUPPL	2015-04-02
32004	SUPPL	2015-04-01
40002	SUPPL	2014-03-19
32003	SUPPL	2013-11-06
18943	SUPPL	2013-11-04
9794	SUPPL	2012-10-02
9793	SUPPL	2012-10-02
40001	SUPPL	2012-10-01
39999	SUPPL	2012-10-01
32002	SUPPL	2012-04-18
40000	SUPPL	2012-04-16
39997	SUPPL	2012-02-17
32000	SUPPL	2012-02-17
18942	SUPPL	2012-02-06
9792	SUPPL	2012-02-06
39998	SUPPL	2012-01-31
32001	SUPPL	2012-01-30
9791	SUPPL	2011-11-07
18941	SUPPL	2011-11-04
39996	SUPPL	2011-10-20
18940	SUPPL	2011-10-20
31999	SUPPL	2011-10-14
9790	SUPPL	2011-10-14
24381	ORIG	2011-08-15
22826	ORIG	2011-08-15
9789	ORIG	2010-12-28
18939	ORIG	2010-12-26