Application 078414

Type: ANDA
Sponsor: OXFORD PHARMS

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
A078414-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07
A078414-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07
A078414-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078414-001	AB
A078414-002	AB
A078414-003	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	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`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	A078414-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078414-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078414-003	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	1080fcea-a5da-499d-a855-690c13559071	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414 ndc (product): 72789-260 ndc (product): 72789-261 ndc (product): 72789-262
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	6f20efca-943b-4bc2-a157-0931bd4d4585	2026-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414 ndc (product): 69584-023 ndc (product): 69584-022 ndc (product): 69584-021
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	ea9f44a1-96cf-496a-8c07-18d8de27e512	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	49104797-8202-1376-e063-6294a90adb38	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	47e494d2-8971-3f8f-e063-6394a90adb20	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Proficient Rx LP	6313edc5-d2d5-44a1-a06f-7f7829c870d2	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	1871ddaf-ed2c-c3ce-e063-6394a90a1bee	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	ffe96aa1-db66-33e4-e053-6394a90a7e4e	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	132c078d-7d31-a6f2-e063-6294a90af095	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	b597d1e1-aba1-4272-bed7-4c95e8150d58	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-2108	Amlodipine Besylate	amlodipine besylate	Par Pharmaceutical	ANDA	Current
0603-2109	Amlodipine Besylate	amlodipine besylate	Par Pharmaceutical	ANDA	Current
0603-2110	Amlodipine Besylate	amlodipine besylate	Par Pharmaceutical	ANDA	Current
43353-684	Amlodipine Besylate	amlodipine besylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-691	Amlodipine Besylate	amlodipine besylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
48433-308	Amlodipine Besylate	amlodipine besylate	Safecor Health, LLC	ANDA	Current
50090-1021	Amlodipine Besylate	amlodipine besylate	A-S Medication Solutions	ANDA	Current
53808-1029	Amlodipine Besylate	amlodipine besylate	State of Florida DOH Central Pharmacy	ANDA	Current
55700-015	Amlodipine Besylate	amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-460	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	DIRECT RX	ANDA	Current
61919-460	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	DIRECT RX	ANDA	Current
63187-143	Amlodipine Besylate	amlodipine besylate	Proficient Rx LP	ANDA	Current
68788-1737	Amlodipine Besylate	amlodipine besylate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-1738	Amlodipine Besylate	amlodipine besylate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69584-021	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-021	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-022	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-022	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-023	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-023	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	ANDA	Current
70518-0812	Amlodipine Besylate	amlodipine besylate	REMEDYREPACK INC.	ANDA	Current
72789-260	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-260	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-260	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-261	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-261	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-261	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-262	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-262	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-262	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current