Application 078381

Type: ANDA
Sponsor: PAR PHARM

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
005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;40MG	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	Approval date
A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29
A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29
A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29
A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29
A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29
A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`

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	A078381-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078381-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078381-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078381-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-006	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 2 of 2 · 26 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	Lupin Pharmaceuticals, Inc.	968c611b-43a7-40f0-9ed3-aa67ee88364b	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	d058e426-8786-4fd3-a771-992e4558c135	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7c75fa72-9b0f-44bf-a745-dfa647ed1e78	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	BluePoint Laboratories	df8e23c8-6c8f-4293-8a37-5ad3d48dba94	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	f12f18bb-7ddb-e7dc-4edd-32f4ac212bca	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	ca014f06-982c-6fe1-9948-a3701dd35d34	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-929	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Par Pharmaceutical Inc.	ANDA	Current
49884-930	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Par Pharmaceutical Inc.	ANDA	Current
49884-931	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Par Pharmaceutical Inc.	ANDA	Current
49884-932	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Par Pharmaceutical Inc.	ANDA	Current
49884-952	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Par Pharmaceutical Inc.	ANDA	Current
49884-953	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Par Pharmaceutical Inc.	ANDA	Current
63629-4878	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	Bryant Ranch Prepack	ANDA	Current