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General MedicationsORALStandard

FAMOTIDINE

FAMOTIDINE

Standard Dose
40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FAMOTIDINE is listed in Drugs@FDA under application 218631 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FAMOTIDINE Form and strength TABLET;ORAL - 40MG Sponsor REGCON HOLDINGS Submission history Latest submission status date: 2025-03-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview FAMOTIDINE is listed in Drugs@FDA under application 218631 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FAMOTIDINE Form and strength TABLET;ORAL - 40MG Sponsor REGCON HOLDINGS Submission history Latest submission status date: 2025-03-25 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.