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General MedicationsORALGeneric

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

Standard Dose
5MG;500MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: None (Tentative Approval)
  • Approval overview EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 212373 (ANDA).
  • Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE Form and strength TABLET;ORAL - 5MG;500MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-07-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 212373 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE Form and strength TABLET;ORAL - 5MG;500MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-07-16 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.