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 3 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	REMEDYREPACK INC.	204f27e9-5041-4677-b313-866ca69abad9	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	4a2bba2d-9b7a-f43a-e063-6294a90af80e	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	41496b0d-f1ca-4e9d-e063-6394a90aec1d	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	49104797-8202-1376-e063-6294a90adb38	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	3ab4ad3d-7795-058a-e063-6294a90abc86	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	743ae641-14e1-456b-80e6-c6f7d621e969	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	6e038d92-09f3-4517-947e-146d007114b8	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	AvKARE	feb9438a-9cbc-4855-e053-6394a90af15e	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	47e494d2-8971-3f8f-e063-6394a90adb20	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	e01efe66-2f31-4261-92ca-0b41f27104da	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f2b8274b-d849-6793-e053-2a95a90aa0e8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f32bb322-68d7-a4ca-e053-2995a90aa7b0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Northwind Health Company, LLC	0c5784b9-5542-144f-e063-6394a90a7ebc	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Northwind Health Company, LLC	03fe9ad2-3a1a-78db-e063-6294a90a2ed3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	0de6a6d0-a114-e114-e063-6394a90a34dd	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	090f3e51-8129-4b5d-97f9-ab410e14df2d	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Ascend Laboratories, LLC	2b0bcb95-dc85-46f7-8b69-ca55cd58b30e	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	QPharma Inc	3f74ed2b-4712-4026-ac2c-9239a211dde3	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Cipla USA Inc.	5409b296-3bed-47cd-abba-9fe6f6833af6	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	41af64c4-b788-d827-e063-6394a90a9157	2025-10-21	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