Application 077073

Type: ANDA
Sponsor: CIPLA

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 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
A077073-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26
A077073-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26
A077073-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077073-001	AB
A077073-002	AB
A077073-003	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 · 129 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	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077073-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077073-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077073-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077073-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077073-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077073-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077073-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077073-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077073-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077073-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077073-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077073-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077073-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077073-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077073-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077073-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077073-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077073-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077073-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077073-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077073-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077073-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077073-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077073-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077073-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077073-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077073-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077073-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077073-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077073-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077073-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077073-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077073-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077073-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077073-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077073-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077073-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077073-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077073-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077073-001	AB	1	`301d65b070ca…`

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Redpharm Drug	58336a97-807a-2859-e063-6294a90ad338	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	NuCare Pharmaceuticals, Inc.	4926f00c-ee19-3e10-e054-00144ff88e88	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d09173a1-5e3c-4c86-8c7c-15238925ef50	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073 ndc (product): 70518-0835
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	f546047f-1cc6-4bbe-a67b-b5c9815b89af	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073 ndc (product): 71335-0473
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	215e0890-0484-45e8-a731-aea53821ad8e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073 ndc (product): 71335-0218
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	aec7618e-c9da-431f-8b6a-14aa399242f6	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	e01efe66-2f31-4261-92ca-0b41f27104da	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Northwind Health Company, LLC	0c5784b9-5542-144f-e063-6394a90a7ebc	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Northwind Health Company, LLC	03fe9ad2-3a1a-78db-e063-6294a90a2ed3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Cipla USA Inc.	5409b296-3bed-47cd-abba-9fe6f6833af6	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Quallent Pharmaceuticals Health LLC	c262dedb-1d13-4447-9355-f11e1dbbfb4d	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073 ndc (product): 82009-026 ndc (product): 82009-028 ndc (product): 82009-027
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Proficient Rx LP	410aa0a5-43cf-455c-b51d-7dfbc24eee32	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073

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 2 of 2 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0835	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-0835	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-0835	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-0835	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70518-0835	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	ANDA	Current
70934-067	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc.	ANDA	Current
70934-067	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-067	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-067	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0218	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0218	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0218	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0218	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0473	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0473	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0473	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0473	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
71335-0511	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	ANDA	Current
82009-026	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	quallent pharmaceuticals health llc	ANDA	Current
82009-027	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	quallent pharmaceuticals health llc	ANDA	Current
82009-028	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	quallent pharmaceuticals health llc	ANDA	Current