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General MedicationsORALGeneric

METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE

METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE

Standard Dose
50MG/500MG;50MG/1000MG
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 208535 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE Form and strength TABLET;ORAL - 50MG/500MG;50MG/1000MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2017-07-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE is listed in Drugs@FDA under application 208535 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE Form and strength TABLET;ORAL - 50MG/500MG;50MG/1000MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2017-07-03 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE (METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE) | Drug Monograph | MedicHelpline