Application 078477

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 2.5MG BASE	No	No
002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 5MG BASE	No	No
003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 10MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078477-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16
A078477-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16
A078477-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16

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 4 · 129 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	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078477-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078477-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078477-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-01-16	`301d65b070ca…`

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 7 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	afcffa7b-03b7-499a-b50c-37b0e28c7737	2021-05-11	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	9f327d08-7661-4088-b554-2f9a99a113e7	2020-10-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Cipla USA Inc.	0c8d6b2f-3e4a-47a2-80e2-a34dcb337555	2020-09-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Proficient Rx LP	410aa0a5-43cf-455c-b51d-7dfbc24eee32	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Norvasc	AMLODIPINE BESYLATE	PFIZER LABORATORIES DIV PFIZER INC	abd6a2ca-40c2-485c-bc53-db1c652505ed	2019-01-15	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	17e6d552-7528-4597-9498-104cb04f32e7	2017-10-25	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58517-120	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	New Horizon Rx Group, LLC	ANDA	Current
65162-006	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-006	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-006	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-006	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-007	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-007	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-007	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-007	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-008	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-008	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-008	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-008	Amlodipine Besylate	Amlodipine Besylate	Amneal Pharmaceuticals LLC	ANDA	Current