General MedicationsORALGeneric

IRBESARTAN; HYDROCHLOROTHIAZIDE

IRBESARTAN: HYDROCHLOROTHIAZIDE

Standard Dose

300MG; 25MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview IRBESARTAN; HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 202414 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient IRBESARTAN: HYDROCHLOROTHIAZIDE Form and strength TABLET; ORAL - 300MG; 25MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-11-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview IRBESARTAN; HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 202414 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient IRBESARTAN: HYDROCHLOROTHIAZIDE Form and strength TABLET; ORAL - 300MG; 25MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-11-25 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.