Application 020364

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 2.5MG BASE;10MG	Yes	No
003	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;10MG	Yes	No
004	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;20MG	Yes	No
005	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;20MG	Yes	No
006	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;40MG	Yes	Yes
007	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;40MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N020364-002	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-003	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-004	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-005	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	RLD	2002-06-20
N020364-006	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	RLD	2006-04-11
N020364-007	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	RLD	2006-04-11

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020364-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020364-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-005	AB	1	`2680178bc6a6…`

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
Lotrel	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	94ae6054-b7ae-4212-a567-4f803af8f2c7	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020364 application number: NDA020364 ndc (product): 0078-0405 ndc (product): 0078-0379 ndc (product): 0078-0406 ndc (product): 0078-0364

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0384	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0404	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0615-1397	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-1398	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-1399	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0781-2271	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2272	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2273	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2274	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2277	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2279	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
43063-233	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68151-1363	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-1365	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67881	SUPPL	2021-06-24
67138	SUPPL	2021-04-22
61861	SUPPL	2020-02-11
61859	SUPPL	2020-02-11
49072	SUPPL	2017-07-25
49050	SUPPL	2017-07-25
34560	SUPPL	2015-05-21
24854	SUPPL	2015-05-19
12490	SUPPL	2015-04-24
24853	SUPPL	2015-04-23
34559	SUPPL	2015-01-05
24852	SUPPL	2014-12-30
24851	SUPPL	2012-10-10
2396	SUPPL	2012-10-10
34558	SUPPL	2012-10-09
12489	SUPPL	2012-10-09
34557	SUPPL	2012-01-23
24850	SUPPL	2012-01-23
12488	SUPPL	2011-11-01
2395	SUPPL	2011-10-31
34556	SUPPL	2011-07-07
24849	SUPPL	2011-06-29
24848	SUPPL	2011-01-07
12487	SUPPL	2011-01-05
34554	SUPPL	2010-04-04
24847	SUPPL	2010-04-02
2394	SUPPL	2010-01-05
34555	SUPPL	2010-01-04
24846	SUPPL	2009-11-19
12486	SUPPL	2009-10-30
24845	SUPPL	2007-09-06
12485	SUPPL	2007-09-04
2393	SUPPL	2007-03-06
24843	SUPPL	2006-04-13
12483	SUPPL	2006-04-12
2392	SUPPL	2004-08-12
12484	SUPPL	2004-07-07
24844	SUPPL	2004-07-06
2391	SUPPL	2003-09-09
20611	SUPPL	2002-11-22
24842	SUPPL	2002-06-20
12482	SUPPL	2002-06-20
41302	SUPPL	2001-08-21
34553	SUPPL	1999-06-16
24841	SUPPL	1999-06-16
41301	SUPPL	1997-03-14