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General MedicationsORALGeneric

SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

SAXAGLIPTIN;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 SAXAGLIPTIN;METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 205942 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SAXAGLIPTIN;METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 5MG;500MG Sponsor AMNEAL PHARMS Submission history Latest submission status date: 2016-01-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview SAXAGLIPTIN;METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 205942 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SAXAGLIPTIN;METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 5MG;500MG Sponsor AMNEAL PHARMS Submission history Latest submission status date: 2016-01-21 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.