Application 078925

Type: ANDA
Sponsor: ALKEM

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
A078925-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04
A078925-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04
A078925-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078925-001	AB
A078925-002	AB
A078925-003	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	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`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	A078925-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078925-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078925-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078925-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078925-001	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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	6efc0ef6-0424-44fc-a9ea-eb30c3b83239	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	58a67272-c4c7-4e2c-85a5-9d39034d12c3	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	4ad016ec-e158-4325-9f45-4460cf78dd98	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Unit Dose Solutions, Inc.	5467eee5-1519-7859-e063-6294a90afed1	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	61cb7f91-d1f6-40bd-98a3-c461098a20d9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Coupler LLC	2904c6e1-2c51-8035-e063-6294a90aa04b	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	72dafc2f-5266-442b-914a-61d1ef1f7ab8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d2f66b58-78ec-456b-8397-2120a223827c	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	cd305e6e-9107-4d25-9918-8d0d9b9ba1ca	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	50204e86-a345-4d2f-b62f-a548787e197f	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals, Inc.	01139e81-a4fa-4e13-acdf-c75c79a1aa9c	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1ff04bd2-9926-48a4-9afc-eab0789dba01	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	204f27e9-5041-4677-b313-866ca69abad9	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	6e038d92-09f3-4517-947e-146d007114b8	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f2b8274b-d849-6793-e053-2a95a90aa0e8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f32bb322-68d7-a4ca-e053-2995a90aa7b0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Ascend Laboratories, LLC	2b0bcb95-dc85-46f7-8b69-ca55cd58b30e	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	QPharma Inc	3f74ed2b-4712-4026-ac2c-9239a211dde3	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925 ndc (product): 42708-066
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	47114f60-4151-43d4-ac2d-adc49492a679	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925 ndc (product): 43063-041
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925 ndc (product): 43063-564

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 147 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8429	Amlodipine Besylate	Amlodipine besylate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8430	Amlodipine Besylate	Amlodipine besylate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8431	Amlodipine Besylate	Amlodipine besylate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
42708-066	Amlodipine Besylate	Amlodipine besylate	QPharma Inc	ANDA	Current
42708-066	Amlodipine Besylate	Amlodipine besylate	QPharma Inc	ANDA	Current
42708-066	Amlodipine Besylate	Amlodipine besylate	QPharma Inc	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1627	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-1627	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-1627	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2524	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2524	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-5059	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
53002-2352	Amlodipine Besylate	Amlodipine besylate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2352	Amlodipine Besylate	Amlodipine besylate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3351	Amlodipine Besylate	Amlodipine besylate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-738	Amlodipine Besylate	Amlodipine besylate	Quality Care Products, LLC	ANDA	Current
55700-738	Amlodipine Besylate	Amlodipine besylate	Quality Care Products, LLC	ANDA	Current
60687-477	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-488	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-488	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-488	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-496	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-496	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-496	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60760-614	Amlodipine Besylate	Amlodipine besylate	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-783	Amlodipine Besylate	Amlodipine besylate	Proficient Rx LP	ANDA	Current
63187-783	Amlodipine Besylate	Amlodipine besylate	Proficient Rx LP	ANDA	Current
63187-783	Amlodipine Besylate	Amlodipine besylate	Proficient Rx LP	ANDA	Current
63629-7640	Amlodipine Besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-7640	Amlodipine Besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
67046-036	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-036	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-684	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services- PA	ANDA	Current
67046-684	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services- PA	ANDA	Current
67296-1530	Amlodipine Besylate	Amlodipine Besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1530	Amlodipine Besylate	Amlodipine Besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1530	Amlodipine Besylate	Amlodipine Besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1648	Amlodipine Besylate	Amlodipine besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1648	Amlodipine Besylate	Amlodipine besylate	RedPharm Drug, Inc.	ANDA	Current
67877-197	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-197	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-197	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-198	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-198	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-198	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-199	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-199	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current