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General MedicationsTABLET, EXTENDED RELEASEGeneric

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

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

Approval overview DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 211559 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE - 5MG/500MG Sponsor MACLEODS PHARMACEUTICALS LTD Submission history Latest submission status date: 2025-08-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 211559 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE - 5MG/500MG Sponsor MACLEODS PHARMACEUTICALS LTD Submission history Latest submission status date: 2025-08-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) | Drug Monograph | MedicHelpline