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 6 of 7 · 126 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	Aphena Pharma Solutions - Tennessee, LLC	132c078d-7d31-a6f2-e063-6294a90af095	2024-03-08	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	52daa759-3327-461a-8cfc-3c6253df91ec	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Teva Pharmaceuticals, Inc.	47edc328-2444-4ca1-a5c1-7c83141e105c	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	498a9b21-34b9-4373-930b-5ed43201a345	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	e8958997-f098-44ce-8c21-b7064d1a962e	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	5c50c3fe-afe5-459e-95c0-c9af4cbb6909	2023-11-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	4512feee-a09d-4244-bc03-c43193e53a0e	2023-09-20	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	d830173d-7676-4490-ab3d-d3515df9ad2e	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee1	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	ced6d26e-8c54-4808-88b6-446344f4acd0	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	186b6149-9610-4380-9bf2-941646069276	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	b597d1e1-aba1-4272-bed7-4c95e8150d58	2023-04-19	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Exelan Pharmaceuticals, Inc.	efd9eda5-f497-45a3-ae13-dee729add999	2023-03-23	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
Norvasc	AMLODIPINE BESYLATE	Viatris Specialty LLC	7367289c-b0b0-466a-83e2-558e2985c29f	2023-02-15	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Unichem Pharmaceuticals (USA), Inc.	a516b336-8f60-4b86-8921-c7d6c07629f2	2022-12-05	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	f3482709-c5c3-4bd0-8067-ad57f31bb525	2022-10-18	Warnings, Adverse reactions	Name fallback brand name: amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	445d1274-7249-476b-ad90-ff93aee56f6d	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine besylate	AMLODIPINE BESYLATE	Exelan Pharmaceuticals, Inc.	1a24433f-4464-4c6d-9456-ed1ce38e8ec4	2022-03-12	Warnings, Adverse reactions	Name fallback brand name: Amlodipine besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	c2c51ec3-ffb0-4240-b048-a8e424775a76	2021-08-01	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