Application 200175

Type: NDA
Sponsor: DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;12.5MG;20MG	Yes	No
002	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;12.5MG;40MG	Yes	No
003	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;25MG;40MG	Yes	No
004	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;12.5MG;40MG	Yes	No
005	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;25MG;40MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200175-001	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-002	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-003	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-004	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23
N200175-005	TRIBENZOR	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N200175-001	AB
N200175-002	AB
N200175-003	AB
N200175-004	AB
N200175-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-001	TRIBENZOR	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-002	TRIBENZOR	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-003	TRIBENZOR	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-004	TRIBENZOR	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	RLD	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-005	TRIBENZOR	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N200175-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200175-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200175-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200175-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-005	AB	1	`03ed91905a0d…`

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
Tribenzor	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Cosette Pharmaceuticals, Inc.	2f56d0bc-236b-41a0-9fc0-21cdfea8d890	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200175 application number: NDA200175 ndc (product): 0713-0874 ndc (product): 0713-0876 ndc (product): 0713-0878 ndc (product): 0713-0877 ndc (product): 0713-0875

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 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0874	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0874	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0875	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0875	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0876	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0876	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0877	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0877	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0878	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0878	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Cosette Pharmaceuticals, Inc.	NDA	Current
53808-1120	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	DOH CENTRAL PHARMACY	NDA	Current
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-114	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-115	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-116	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-117	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
65597-118	Tribenzor	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Daiichi Sankyo, Inc.	NDA	Current
70518-1648	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	REMEDYREPACK INC.	NDA	Current
70518-1648	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	REMEDYREPACK INC.	NDA	Current
70518-1648	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	REMEDYREPACK INC.	NDA	Current
70518-1648	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64875	SUPPL	2020-10-07
64823	SUPPL	2020-10-05
64360	SUPPL	2020-08-21
64341	SUPPL	2020-08-21
46835	SUPPL	2017-01-13
46724	SUPPL	2017-01-05
45772	SUPPL	2016-11-02
45769	SUPPL	2016-11-02
40010	SUPPL	2014-09-26
32012	SUPPL	2014-09-24
18951	SUPPL	2014-07-01
9805	SUPPL	2014-06-30
9804	SUPPL	2014-06-18
40009	SUPPL	2014-06-17
40008	SUPPL	2013-07-05
32011	SUPPL	2013-07-05
40007	SUPPL	2012-12-14
32010	SUPPL	2012-12-11
9803	SUPPL	2012-10-03
18950	SUPPL	2012-10-02
18949	SUPPL	2012-01-23
9802	SUPPL	2012-01-23
40006	SUPPL	2011-11-04
9801	SUPPL	2011-11-03
43342	ORIG	2011-07-15
24383	ORIG	2011-07-15
18948	SUPPL	2011-06-29
9800	SUPPL	2011-06-27
18947	SUPPL	2011-04-11
9799	SUPPL	2011-04-06
40005	ORIG	2010-07-30
9798	ORIG	2010-07-28