Home Applications 200175 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.
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.
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
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 2 of 2 · 83 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70518-1648 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1648 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1648 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current