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General MedicationsORALGeneric

GLUCOPHAGE XR

METFORMIN HYDROCHLORIDE

Standard Dose
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Discontinued
Summary

Approval overview GLUCOPHAGE XR is listed in Drugs@FDA under application 021202 (NDA).

Review priority: UNKNOWN Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor EMD SERONO INC Submission history Latest submission status date: 2018-05-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview GLUCOPHAGE XR is listed in Drugs@FDA under application 021202 (NDA). Review priority: UNKNOWN Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor EMD SERONO INC Submission history Latest submission status date: 2018-05-30 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: UNKNOWN

Interaction Notes

  • No interaction notes stored yet.