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General MedicationsORALStandard

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

Standard Dose
500MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 219151 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METFORMIN HYDROCHLORIDE Form and strength SOLUTION;ORAL - 500MG/5ML Sponsor BIONPHARMA Submission history Latest submission status date: 2025-04-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 219151 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METFORMIN HYDROCHLORIDE Form and strength SOLUTION;ORAL - 500MG/5ML Sponsor BIONPHARMA Submission history Latest submission status date: 2025-04-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.