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General MedicationsORALGeneric

DAPAGLIFLOZIN

METFORMIN HYDROCHLORIDE

Standard Dose
5MG; 1GM
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 - 5MG; 1GM 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 - 5MG; 1GM 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.