Application 090245

Type: ANDA
Sponsor: LUPIN

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
A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30
A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30
A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30
A090245-004	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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090245-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090245-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090245-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine and Valsartan	AMLODIPINE AND VALSARTAN	Lupin Pharmaceuticals, Inc.	35086164-bf92-4b3c-9845-f8cd7464c7d6	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090245 application number: ANDA090245 ndc (product): 68180-765 ndc (product): 68180-764 ndc (product): 68180-766 ndc (product): 68180-767

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-880	Amlodipine and Valsartan	Amlodipine and Valsartan	medsource pharmaceuticals	ANDA	Current
45865-882	Amlodipine and Valsartan	Amlodipine and Valsartan	medsource pharmaceuticals	ANDA	Current
45865-889	Amlodipine and Valsartan	Amlodipine and Valsartan	medsource pharmaceuticals	ANDA	Current
57297-764	Amlodipine and Valsartan	Amlodipine and Valsartan	LUPIN LIMITED	ANDA	Current
57297-765	Amlodipine and Valsartan	Amlodipine and Valsartan	LUPIN LIMITED	ANDA	Current
57297-766	Amlodipine and Valsartan	Amlodipine and Valsartan	LUPIN LIMITED	ANDA	Current
57297-767	Amlodipine and Valsartan	Amlodipine and Valsartan	LUPIN LIMITED	ANDA	Current
68180-764	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-764	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-764	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-764	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-764	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-765	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-765	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-765	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-765	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-765	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-766	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-766	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-766	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-766	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-766	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-767	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-767	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-767	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-767	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-767	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current