Application 022026

Type: NDA
Sponsor: SYNTHON PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N022026-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27
N022026-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27
N022026-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022026-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022026-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022026-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-09-27	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2023-01-26 05:58 UTC	2023-01	N022026-002	6828339	2022-11-20	Drug substance	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022026-003	6828339	2022-11-20	Drug substance	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022026-001	6828339	2022-11-20	Drug substance	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022026-002	6828339	2022-11-20	Drug substance	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022026-003	6828339	2022-11-20	Drug substance	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022026-001	6828339	2022-11-20	Drug substance	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022026-002	6828339	2022-11-20	Drug substance	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022026-003	6828339	2022-11-20	Drug substance	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022026-001	6828339	2022-11-20	Drug substance	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022026-002	6828339	2022-11-20	Drug substance	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022026-003	6828339	2022-11-20	Drug substance	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022026-001	6828339	2022-11-20	Drug substance	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022026-002	6828339	2022-11-20	Drug substance	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022026-003	6828339	2022-11-20	Drug substance	`cb3db0bc1861…`

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 7 · 123 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Coupler LLC	5af8493b-2b73-859c-e063-6394a90a4620	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	GSMS, Incorporated	9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	6efc0ef6-0424-44fc-a9ea-eb30c3b83239	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	QPharma, Inc.	5866d1ee-631d-d09e-e063-6294a90abe01	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	58d2fbed-3904-3e31-e063-6294a90af21d	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Redpharm Drug	58336a97-807a-2859-e063-6294a90ad338	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	58a67272-c4c7-4e2c-85a5-9d39034d12c3	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Major Pharmaceuticals	edf9b22c-e37e-4b4e-8a64-20bb036c7d2d	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	1080fcea-a5da-499d-a855-690c13559071	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	NuCare Pharmaceuticals, Inc.	4926f00c-ee19-3e10-e054-00144ff88e88	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	4ad016ec-e158-4325-9f45-4460cf78dd98	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d09173a1-5e3c-4c86-8c7c-15238925ef50	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Unit Dose Solutions, Inc.	5467eee5-1519-7859-e063-6294a90afed1	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Safecor Health LLC	572bc798-c3d9-4fe2-98be-8e1913bda8f3	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	China Resources Saike Pharmaceutical Co., Ltd.	3518853a-4c5b-4161-a178-8da7f656f009	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	61cb7f91-d1f6-40bd-98a3-c461098a20d9	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	f546047f-1cc6-4bbe-a67b-b5c9815b89af	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: AMLODIPINE BESYLATE generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	ST. MARY'S MEDICAL PARK PHARMACY	b2d5cccd-e5ff-2909-e053-2a95a90a9773	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	215e0890-0484-45e8-a731-aea53821ad8e	2026-05-19	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42391	ORIG	2009-02-02
24233	ORIG	2009-02-02
16793	ORIG	2007-10-04
6715	ORIG	2007-10-04