Application 091235

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

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

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	Approval date
A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30
A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30
A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30
A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091235-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091235-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091235-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091235-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30	`5bbf6a4d5a75…`

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	A091235-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091235-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091235-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091235-004	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7690	Amlodipine and Valsartan	Amlodipine and Valsartan	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7692	Amlodipine and Valsartan	Amlodipine and Valsartan	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7693	Amlodipine and Valsartan	Amlodipine and Valsartan	Teva Pharmaceuticals USA, Inc.	ANDA	Current