General MedicationsORALGeneric

IRBESARTAN; HYDROCHLOROTHIAZIDE

Standard Dose

300MG; 12.5MG

Max Dose

Refer to approved labeling

Primary Use

Marketing status: None (Tentative Approval)

Summary

Approval overview IRBESARTAN; HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 090815 (ANDA).

Marketing status: None (Tentative Approval) Active ingredient IRBESARTAN; HYDROCHLOROTHIAZIDE Form and strength TABLET; ORAL - 300MG; 12.5MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2011-02-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview IRBESARTAN; HYDROCHLOROTHIAZIDE is listed in Drugs@FDA under application 090815 (ANDA). Marketing status: None (Tentative Approval) Active ingredient IRBESARTAN; HYDROCHLOROTHIAZIDE Form and strength TABLET; ORAL - 300MG; 12.5MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2011-02-16 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)

Interaction Notes

No interaction notes stored yet.