Application 077215

Type: ANDA
Sponsor: CIPLA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 2.5MG BASE;10MG	No	No
002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;10MG	No	No
003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;20MG	No	No
004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07
A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07
A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07
A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`4b0b4de00fa7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	856a8cdc-57cc-4355-966d-986bbc5fa6e6	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077215 application number: ANDA077215

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-143	Amlodipine besylate and Benazepril hydrochloride	Amlodipine besylate and Benazepril hydrochloride	Cipla USA Inc.	ANDA	Current
69097-144	Amlodipine besylate and Benazepril hydrochloride	Amlodipine besylate and Benazepril hydrochloride	Cipla USA Inc.	ANDA	Current
69097-145	Amlodipine besylate and Benazepril hydrochloride	Amlodipine besylate and Benazepril hydrochloride	Cipla USA Inc.	ANDA	Current
69097-146	Amlodipine besylate and Benazepril hydrochloride	Amlodipine besylate and Benazepril hydrochloride	Cipla USA Inc.	ANDA	Current