Application 091431

Type: ANDA
Sponsor: APOTEX

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 5MG BASE;40MG	No	No
005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;20MG	No	No
006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30
A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30
A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30
A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30
A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30
A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A091431-001	AB
A091431-002	AB
A091431-003	AB
A091431-004	AB
A091431-005	AB
A091431-006	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 7 · 258 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	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091431-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091431-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091431-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091431-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2013-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091431-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2013-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091431-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2013-12-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 7 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A091431-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091431-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091431-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091431-004	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091431-005	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091431-006	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091431-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091431-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091431-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091431-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091431-005	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091431-006	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091431-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091431-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091431-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091431-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091431-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091431-006	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	27b0c628-820a-48bf-a411-86c0ebd4cc8d	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091431 application number: ANDA091431

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.