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General MedicationsFILM COATEDGeneric

METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE

METFORMIN HYDROCHLORIDE || SITAGLIPTIN

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

Approval overview METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE is listed in Drugs@FDA under application 212338 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE || SITAGLIPTIN Form and strength TABLET;FILM COATED - 500MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-01-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE is listed in Drugs@FDA under application 212338 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE || SITAGLIPTIN Form and strength TABLET;FILM COATED - 500MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-01-07 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.