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General MedicationsORALStandard

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Standard Dose
EQ 5MG BASE;12.5MG;20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 210718 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL Form and strength TABLET;ORAL - EQ 5MG BASE;12.5MG;20MG Sponsor PIRAMAL Submission history Latest submission status date: 2025-05-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 210718 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL Form and strength TABLET;ORAL - EQ 5MG BASE;12.5MG;20MG Sponsor PIRAMAL Submission history Latest submission status date: 2025-05-14 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL) | Drug Monograph | MedicHelpline