Application 078226

Type: ANDA
Sponsor: ZYDUS PHARMS USA

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 42.

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	TE codes	Approval date
A078226-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09
A078226-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09
A078226-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078226-001	AB
A078226-002	AB
A078226-003	AB

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078226-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078226-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-001	AB	1	`1e350fbaab3a…`

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Major Pharmaceuticals	edf9b22c-e37e-4b4e-8a64-20bb036c7d2d	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226 ndc (product): 0904-6369 ndc (product): 0904-6371 ndc (product): 0904-6370
Amlodipine Besylate	AMLODIPINE BESYLATE	Safecor Health LLC	572bc798-c3d9-4fe2-98be-8e1913bda8f3	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226
Amlodipine Besylate	AMLODIPINE BESYLATE	Cardinal Health 107, LLC	a74239bf-4684-424c-ba4e-6087e363265b	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226 ndc (product): 55154-6892 ndc (product): 55154-8093 ndc (product): 55154-6875
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Lifesciences Limited	cacb3551-c579-41cb-bed6-4b4d8b0644fc	2024-11-25		Exact identifier application applno (ANDA): 078226 application number: ANDA078226 ndc (product): 65841-622 ndc (product): 65841-621 ndc (product): 65841-620
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Pharmaceuticals USA Inc.	fda0739d-b355-478c-acae-8f773a3ec4b3	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226 ndc (product): 68382-121 ndc (product): 68382-123 ndc (product): 68382-122

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6369	Amlodipine Besylate	Amlodipine Besylate	Major Pharmaceuticals	ANDA	Current
0904-6369	Amlodipine Besylate	Amlodipine Besylate	Major Pharmaceuticals	ANDA	Current
0904-6370	Amlodipine Besylate	Amlodipine Besylate	Major Pharmaceuticals	ANDA	Current
0904-6370	Amlodipine Besylate	Amlodipine Besylate	Major Pharmaceuticals	ANDA	Current
0904-6371	Amlodipine Besylate	Amlodipine Besylate	Major Pharmaceuticals	ANDA	Current
0904-6371	Amlodipine Besylate	Amlodipine Besylate	Major Pharmaceuticals	ANDA	Current
50090-5049	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
55154-6875	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-6875	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-6875	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-6875	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health 107, LLC	ANDA	Current
55154-6892	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-6892	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-6892	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-6892	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health 107, LLC	ANDA	Current
55154-8093	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health, Inc.	ANDA	Current
55154-8093	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health 107, LLC	ANDA	Current
63739-631	Amlodipine Besylate	Amlodipine Besylate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-631	Amlodipine Besylate	Amlodipine Besylate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-631	Amlodipine Besylate	Amlodipine Besylate	McKesson Corporation	ANDA	Current
65841-620	Amlodipine Besylate	Amlodipine Besylate	Zydus Lifesciences Limited	ANDA	Current
65841-620	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-620	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-620	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-621	Amlodipine Besylate	Amlodipine Besylate	Zydus Lifesciences Limited	ANDA	Current
65841-621	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-621	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-621	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-622	Amlodipine Besylate	Amlodipine Besylate	Zydus Lifesciences Limited	ANDA	Current
65841-622	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-622	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
65841-622	Amlodipine Besylate	Amlodipine Besylate	Cadila Healthcare Limited	ANDA	Current
68382-121	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-121	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-121	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-122	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-122	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-122	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-123	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-123	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-123	Amlodipine Besylate	Amlodipine Besylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
76413-141	Amlodipine Besylate	Amlodipine Besylate	Central Texas Community Health Centers	ANDA	Current