Application 201593

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	No	No
002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	No	No
003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	No	No
004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	No	No
005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	No	No

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

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
A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03
A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03
A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03
A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03
A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03

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 3 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`87673890dc5c…`

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	A201593-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-005	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A201593-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201593-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-005	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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-325	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-325	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-326	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-326	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-327	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-327	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-328	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-328	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-329	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
13668-329	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited	ANDA	Current
70518-1220	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1220	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32121	ORIG	2015-06-10
32120	ORIG	2014-11-04