Application 200435

Type: ANDA
Sponsor: TEVA PHARMS

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;25MG;160MG	No	No
004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	No	No
005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	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
A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2012-09-25
A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2012-09-25
A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2012-09-25
A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2012-09-25
A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2012-09-25

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 4 of 6 · 215 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
2020-12-22 03:56 UTC	2020-12	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2012-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2012-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;12.5MG;160MG	TABLET / ORAL		2012-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;25MG;160MG	TABLET / ORAL		2012-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;160MG	TABLET / ORAL		2012-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;320MG	TABLET / ORAL		2012-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;12.5MG;160MG	TABLET / ORAL		2012-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;12.5MG;160MG	TABLET / ORAL		2012-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;25MG;160MG	TABLET / ORAL		2012-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;160MG	TABLET / ORAL		2012-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;320MG	TABLET / ORAL		2012-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;12.5MG;160MG	TABLET / ORAL		2012-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;12.5MG;160MG	TABLET / ORAL	AB	2012-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	5MG;25MG;160MG	TABLET / ORAL	AB	2012-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;160MG	TABLET / ORAL	AB	2012-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;25MG;320MG	TABLET / ORAL	AB	2012-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	10MG;12.5MG;160MG	TABLET / ORAL	AB	2012-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2012-09-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2012-09-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200435-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200435-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200435-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2012-09-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200435-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2012-09-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200435-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2012-09-25	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A200435-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200435-005	AB	1	`ea99ee380514…`

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
9825	ORIG	2012-09-27