General MedicationsTABLETGeneric

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Standard Dose

500MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 214859 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SITAGLIPTIN AND METFORMIN HYDROCHLORIDE Form and strength TABLET - 500MG Sponsor AUROBINDO PHARMA LIMITED Submission history Latest submission status date: 2026-02-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 214859 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SITAGLIPTIN AND METFORMIN HYDROCHLORIDE Form and strength TABLET - 500MG Sponsor AUROBINDO PHARMA LIMITED Submission history Latest submission status date: 2026-02-24 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.