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 2 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	Bryant Ranch Prepack	215e0890-0484-45e8-a731-aea53821ad8e	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Coupler LLC	2904c6e1-2c51-8035-e063-6294a90aa04b	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	5a0b3dd4-91f5-4173-a992-e91b1cac6a18	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	72dafc2f-5266-442b-914a-61d1ef1f7ab8	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d2f66b58-78ec-456b-8397-2120a223827c	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	cd305e6e-9107-4d25-9918-8d0d9b9ba1ca	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	50204e86-a345-4d2f-b62f-a548787e197f	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Lupin Pharmaceuticals, Inc.	003dd1ec-16f8-4f96-b6a8-c4689d35892a	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	988e5acb-356e-4116-b6db-ab8468ed7234	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Cardinal Health 107, LLC	a74239bf-4684-424c-ba4e-6087e363265b	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	6f20efca-943b-4bc2-a157-0931bd4d4585	2026-03-28	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	2cdd0da9-eea6-45e0-b0b7-35413a168a4f	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	215ef2cb-d5b6-43d5-bbd5-195ec57cde2b	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aurobindo Pharma Limited	b6f298ba-2d7e-4a3c-9edb-8b60aba716d6	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e0	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	a6635bb3-b8d5-4046-ac56-27af9bac877e	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	aec7618e-c9da-431f-8b6a-14aa399242f6	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	ea9f44a1-96cf-496a-8c07-18d8de27e512	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals, Inc.	01139e81-a4fa-4e13-acdf-c75c79a1aa9c	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1ff04bd2-9926-48a4-9afc-eab0789dba01	2026-02-23	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