Application 201380

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 5MG BASE	No	No
002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 10MG BASE	No	No
003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 2.5MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201380-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-04-13
A201380-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-04-13
A201380-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2026-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201380-001	AB
A201380-002	AB
A201380-003	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 3 · 89 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
2026-09-14 22:38:34	2026-08	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201380-003	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2026-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201380-003	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2026-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2012-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2012-04-13	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201380-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201380-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201380-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201380-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201380-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201380-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201380-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201380-002	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	A201380-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201380-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A201380-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201380-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201380-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201380-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201380-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201380-002	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201380-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201380-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201380-003	AB	1	`a50c72e98297…`

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 7 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	afcffa7b-03b7-499a-b50c-37b0e28c7737	2021-05-11	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	9f327d08-7661-4088-b554-2f9a99a113e7	2020-10-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Cipla USA Inc.	0c8d6b2f-3e4a-47a2-80e2-a34dcb337555	2020-09-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Proficient Rx LP	410aa0a5-43cf-455c-b51d-7dfbc24eee32	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Norvasc	AMLODIPINE BESYLATE	PFIZER LABORATORIES DIV PFIZER INC	abd6a2ca-40c2-485c-bc53-db1c652505ed	2019-01-15	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	17e6d552-7528-4597-9498-104cb04f32e7	2017-10-25	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-015	Amlodipine	Amlodipine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-016	Amlodipine	Amlodipine	Macleods Pharmaceuticals Limited	ANDA	Current