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General MedicationsORALStandard

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Standard Dose
1GM;EQ 5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 207678 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2023-08-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 207678 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2023-08-09 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.