Home Applications 210718 Application 210718
Type ANDA
Sponsor PIRAMAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG No No 002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG No No 003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG No No 004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG No No 005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A210718-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-05-14 A210718-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 A210718-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 A210718-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 A210718-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14
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.
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 A210718-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210718-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210718-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210718-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210718-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210718-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210718-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210718-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210718-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210718-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210718-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210718-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210718-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210718-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210718-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210718-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210718-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210718-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210718-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210718-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210718-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210718-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210718-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210718-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210718-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-05-14 a50c72e98297…
Observed Orange Book normalized TE history# 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.