Application 078552

Type: ANDA
Sponsor: EPIC PHARMA LLC

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
A078552-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08
A078552-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08
A078552-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078552-001	AB
A078552-002	AB
A078552-003	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	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`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	A078552-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078552-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078552-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078552-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078552-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	215ef2cb-d5b6-43d5-bbd5-195ec57cde2b	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552 ndc (product): 68645-580
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	090f3e51-8129-4b5d-97f9-ab410e14df2d	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552 ndc (product): 42806-055 ndc (product): 42806-057 ndc (product): 42806-056
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	d17ef907-7719-4246-8ade-b67afdfaf787	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552 ndc (product): 71610-620
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	186b6149-9610-4380-9bf2-941646069276	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-524	Amlodipine Besylate	Amlodipine Besylate	Marlex Pharmaceuticals Inc	ANDA	Current
10135-525	Amlodipine Besylate	Amlodipine Besylate	Marlex Pharmaceuticals Inc	ANDA	Current
10135-526	Amlodipine Besylate	Amlodipine Besylate	Marlex Pharmaceuticals Inc	ANDA	Current
42806-055	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	ANDA	Current
42806-055	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	ANDA	Current
42806-056	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	ANDA	Current
42806-056	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	ANDA	Current
42806-057	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	ANDA	Current
42806-057	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	ANDA	Current
50268-083	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	AvPAK	ANDA	Current
50268-084	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	AvPAK	ANDA	Current
50268-084	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	AvPAK	ANDA	Current
50268-085	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	AvPAK	ANDA	Current
50268-085	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	AvPAK	ANDA	Current
53808-1100	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	DOH CENTRAL PHARMACY	ANDA	Current
55154-4331	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Cardinal Health	ANDA	Current
55154-4331	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health	ANDA	Current
55154-4331	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health	ANDA	Current
57664-055	Amlodipine Besylate	AMLODIPINE BESYLATE	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-056	Amlodipine Besylate	AMLODIPINE BESYLATE	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-057	Amlodipine Besylate	AMLODIPINE BESYLATE	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
68071-3327	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68645-580	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-580	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-580	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
70518-1622	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-1622	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-1677	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-1677	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70934-288	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-288	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-288	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71610-620	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current