Application 021532

Type: NDA
Sponsor: DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	12.5MG;20MG	Yes	No
003	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	12.5MG;40MG	Yes	No
005	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	25MG;40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021532-002	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05
N021532-003	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05
N021532-005	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021532-002	AB
N021532-003	AB
N021532-005	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 4 · 126 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
2026-08-18 06:07:40	2026-07	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021532-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021532-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021532-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021532-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021532-002	AB	1	`1e350fbaab3a…`

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
olmesartan medoxomil-hydrochlorothiazide	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	AvKARE	569596a2-98f0-116a-e063-6294a90a3fa1	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532
Benicar HCT	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	Cosette Pharmaceuticals, Inc.	a90915ca-f9d3-4fff-8370-d5dc4cdfc521	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532
olmesartan medoxomil-hydrochlorothiazide	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	AvKARE	017bc6a3-5b3d-2381-e063-6394a90abece	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532
Benicar HCT	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	Cosette Pharmaceuticals, Inc.	881a1c32-c209-4038-9c5e-c5e46c6e0546	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532 ndc (product): 0713-0863 ndc (product): 0713-0865 ndc (product): 0713-0864

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0863	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0863	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0864	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0864	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0865	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0865	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
50090-1083	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	A-S Medication Solutions	NDA	Current
50090-1083	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	A-S Medication Solutions	NDA	Current
50090-4329	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	A-S Medication Solutions	NDA	Current
55289-443	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
57664-758	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-758	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-758	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-758	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-758	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-759	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-759	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-759	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-759	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-759	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-760	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-760	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-760	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-760	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-760	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
71335-0203	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
71335-0203	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
71335-0203	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81997	SUPPL	2025-04-25
81929	SUPPL	2025-04-16
64437	SUPPL	2020-08-27
64357	SUPPL	2020-08-21
37173	SUPPL	2016-02-18
28044	SUPPL	2016-02-12
15709	SUPPL	2014-09-26
5667	SUPPL	2014-09-24
15708	SUPPL	2014-06-30
5666	SUPPL	2014-06-30
28046	SUPPL	2014-06-17
15707	SUPPL	2014-06-17
37175	SUPPL	2013-07-05
5665	SUPPL	2013-07-05
15706	SUPPL	2012-12-14
5664	SUPPL	2012-12-11
28045	SUPPL	2012-09-24
15705	SUPPL	2012-09-20
37174	SUPPL	2012-01-30
5663	SUPPL	2012-01-20
15704	SUPPL	2011-05-05
15703	SUPPL	2011-05-05
5662	SUPPL	2011-05-05
5661	SUPPL	2011-05-05
5660	SUPPL	2007-11-19
37172	SUPPL	2005-07-15
28043	SUPPL	2005-07-15
5659	SUPPL	2004-11-16
21720	ORIG	2003-09-10
37171	ORIG	2003-06-08
28042	ORIG	2003-06-08