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General MedicationsORALGeneric

TAMBOCOR

FLECAINIDE ACETATE

Standard Dose
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: STANDARD Marketing status: Discontinued
Summary

Approval overview TAMBOCOR is listed in Drugs@FDA under application 018830 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FLECAINIDE ACETATE Form and strength TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ALVOGEN Submission history Latest submission status date: 2016-09-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview TAMBOCOR is listed in Drugs@FDA under application 018830 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FLECAINIDE ACETATE Form and strength TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ALVOGEN Submission history Latest submission status date: 2016-09-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
TAMBOCOR (FLECAINIDE ACETATE) | Drug Monograph | MedicHelpline