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General MedicationsORALGeneric

ZELNORM

TEGASEROD MALEATE

Standard Dose
EQ 6MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ZELNORM is listed in Drugs@FDA under application 021200 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient TEGASEROD MALEATE Form and strength TABLET;ORAL - EQ 6MG BASE Sponsor ALFASIGMA Submission history Latest submission status date: 2019-03-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZELNORM is listed in Drugs@FDA under application 021200 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TEGASEROD MALEATE Form and strength TABLET;ORAL - EQ 6MG BASE Sponsor ALFASIGMA Submission history Latest submission status date: 2019-03-29 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.