General MedicationsORALStandard

OSENI

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Standard Dose

EQ 25MG BASE;EQ 15MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview OSENI is listed in Drugs@FDA under application 022426 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 25MG BASE;EQ 15MG BASE Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2024-06-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview OSENI is listed in Drugs@FDA under application 022426 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 25MG BASE;EQ 15MG BASE Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2024-06-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.