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 4 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	PD-Rx Pharmaceuticals, Inc.	47114f60-4151-43d4-ac2d-adc49492a679	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Quallent Pharmaceuticals Health LLC	c262dedb-1d13-4447-9355-f11e1dbbfb4d	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	3ce6978a-6ab3-33a9-e063-6294a90a24a1	2025-08-21	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	0c7d1f99-dfe0-7041-e063-6294a90a9705	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	2437a130-d544-6db4-e063-6394a90a0d4d	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	921096ab-589a-4821-8d91-a6319f4a559a	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	dc2107cd-edfa-44a6-b139-edee6ccf47ce	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	00a037f6-b17f-4d21-9a9a-0e682f68d483	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	313fe7ba-2fbd-bb4d-e063-6294a90a3749	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Proficient Rx LP	6313edc5-d2d5-44a1-a06f-7f7829c870d2	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	fc61eee9-ee15-9078-e053-6394a90a22f4	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	DIRECT RX	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	47f228e9-4a34-4d14-988d-b06af90124b9	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	1871ddaf-ed2c-c3ce-e063-6394a90a1bee	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Quality Care Products, LLC	a75e4797-6b7f-4366-9105-79d6877adac5	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Quality Care Products, LLC	6b7c18ef-3a85-4ae3-9135-7ac30a0dde08	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
amlodipine besylate	AMLODIPINE BESYLATE	Mylan Pharmaceuticals Inc.	180ee374-24f2-4b9c-9d54-8815f2b1dc9b	2024-11-28	Warnings, Adverse reactions	Name fallback brand name: amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Lifesciences Limited	cacb3551-c579-41cb-bed6-4b4d8b0644fc	2024-11-25		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