Application 078573

Type: ANDA
Sponsor: TORRENT PHARMS

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 1.

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	Approval date
A078573-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22
A078573-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22
A078573-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078573-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078573-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078573-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A078573-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078573-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078573-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078573-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078573-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078573-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078573-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078573-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078573-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078573-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078573-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078573-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078573-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078573-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078573-003	AB	1	`ea99ee380514…`

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 · 125 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 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	NCS HealthCare of KY, LLC dba Vangard Labs	6efc0ef6-0424-44fc-a9ea-eb30c3b83239	2026-05-28	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
Amlodipine Besylate	AMLODIPINE BESYLATE	Coupler LLC	2904c6e1-2c51-8035-e063-6294a90aa04b	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	5a0b3dd4-91f5-4173-a992-e91b1cac6a18	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	72dafc2f-5266-442b-914a-61d1ef1f7ab8	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d2f66b58-78ec-456b-8397-2120a223827c	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	cd305e6e-9107-4d25-9918-8d0d9b9ba1ca	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	50204e86-a345-4d2f-b62f-a548787e197f	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate generic name: AMLODIPINE BESYLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-022	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-022	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-023	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-023	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-024	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-024	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current