Application 020033

Type: NDA
Sponsor: US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;12.5MG	Yes	No
003	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;25MG	Yes	Yes
004	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;12.5MG	Yes	No

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

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	TE codes	RLD / RS	Approval date
N020033-001	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19
N020033-002	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19
N020033-003	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RLD	1992-05-19
N020033-004	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020033-002	AB
N020033-003	AB
N020033-004	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 5 · 164 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	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD	1992-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N020033-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020033-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020033-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020033-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020033-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020033-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020033-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020033-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020033-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020033-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020033-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020033-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020033-002	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotensin HCT	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Validus Pharmaceuticals LLC	94c4536f-e28e-48b1-8336-b3939917e99d	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033 ndc (product): 30698-452 ndc (product): 30698-453 ndc (product): 30698-454
benazepril hydrochloride and hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Advagen Pharma Ltd	3f6e6da8-6da3-47c5-a151-e6fd7206890e	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033
benazepril hydrochloride and hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f4120568-dd9b-47a5-bd44-4de6ed343bbe	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033
benazepril hydrochloride and hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Padagis US LLC	3e2d3974-38b0-49d0-8020-f74107584724	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033 ndc (product): 0574-0227 ndc (product): 0574-0229 ndc (product): 0574-0228

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0227	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-0227	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-0227	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC.	NDA AUTHORIZED GENERIC	Current
0574-0227	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-0227	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-0228	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-0228	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-0228	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC.	NDA AUTHORIZED GENERIC	Current
0574-0228	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-0228	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-0229	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-0229	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-0229	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC.	NDA AUTHORIZED GENERIC	Current
0574-0229	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-0229	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
30698-452	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-452	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-452	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-452	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-453	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-453	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-453	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-453	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-454	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-454	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-454	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
30698-454	Lotensin HCT	benazepril hydrochloride and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current
64980-194	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-194	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-195	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-195	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-196	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-196	benazepril hydrochloride and hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64352	SUPPL	2020-08-21
64338	SUPPL	2020-08-21
55413	SUPPL	2018-09-10
55160	SUPPL	2018-08-10
49265	SUPPL	2017-08-07
49253	SUPPL	2017-08-07
1935	SUPPL	2015-08-27
34198	SUPPL	2015-08-26
34197	SUPPL	2014-12-16
1934	SUPPL	2014-12-15
34196	SUPPL	2012-09-25
34195	SUPPL	2012-07-30
1933	SUPPL	2012-07-30
34194	SUPPL	2012-02-17
1932	SUPPL	2012-02-17
21063	SUPPL	2012-02-06
12151	SUPPL	2012-01-23
12150	SUPPL	2011-06-16
1931	SUPPL	2011-06-16
12149	SUPPL	2011-03-21
1930	SUPPL	2011-03-21
1929	SUPPL	2010-01-19
34193	SUPPL	2009-11-12
21062	SUPPL	2009-01-26
1928	SUPPL	2008-06-02
21061	SUPPL	2007-02-12
21060	SUPPL	2003-11-05