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 5 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	Proficient Rx LP	f18148f9-42b2-43dc-9cf8-212d9121dc5f	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Pharmaceuticals USA Inc.	fda0739d-b355-478c-acae-8f773a3ec4b3	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	91e11ca6-05fb-47be-bd40-f8649a35d47d	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	3bd019d3-b58c-44ab-9190-606a0af5e9b6	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	da4e36d3-1ddc-4350-9a00-86975e523f75	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	49d69d27-2a75-4a07-bfb9-24f8af853138	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	b1151904-5085-49bd-94ec-cb2894f4eb10	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	1b449c22-0181-4a50-94b3-26139b90b978	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	b4cc6d7e-923b-e81c-e053-2995a90a0731	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Ascend Laboratories, LLC	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	9c448d87-294e-3325-e053-2a95a90a2299	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	094498f2-11d9-2a05-e063-6294a90ab2e1	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	5a67bbdc-ac1f-4778-bbdc-929df140b7f5	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	638d86ab-986b-59ed-e053-2a91aa0a98ee	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	ca8c6ca7-79c6-5299-e053-2a95a90a790d	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	c3742b31-11f6-4c11-98e3-75916a1982d4	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	f968393f-47d2-4c16-b34f-93a9d61adb9e	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	d17ef907-7719-4246-8ade-b67afdfaf787	2024-03-26	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	ffe96aa1-db66-33e4-e053-6394a90a7e4e	2024-03-26	Warnings, Adverse reactions	Name fallback 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