General MedicationsORALStandard

IRBESARTAN AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; IRBESARTAN

Standard Dose

25MG;300MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview IRBESARTAN AND HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 203630 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCHLOROTHIAZIDE; IRBESARTAN Form and strength TABLET;ORAL - 25MG;300MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-11-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview IRBESARTAN AND HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 203630 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCHLOROTHIAZIDE; IRBESARTAN Form and strength TABLET;ORAL - 25MG;300MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-11-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.