General MedicationsORALGeneric

DAPAGLIFLOZIN

METFORMIN HYDROCHLORIDE

Standard Dose

10MG; 500MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview DAPAGLIFLOZIN is listed in Drugs@FDA under application 211479 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE; ORAL - 10MG; 500MG Sponsor MSN LABS PVT LTD Submission history Latest submission status date: 2020-05-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview DAPAGLIFLOZIN is listed in Drugs@FDA under application 211479 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE; ORAL - 10MG; 500MG Sponsor MSN LABS PVT LTD Submission history Latest submission status date: 2020-05-01 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.