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General MedicationsTABLET, EXTENDED RELEASEGeneric

EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 220511 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE - 10MG Sponsor AJANTA PHARMA LTD Submission history Latest submission status date: 2026-02-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 220511 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE - 10MG Sponsor AJANTA PHARMA LTD Submission history Latest submission status date: 2026-02-25 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.