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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078226-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078226-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078226-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	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	Major Pharmaceuticals	edf9b22c-e37e-4b4e-8a64-20bb036c7d2d	2025-09-05	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	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