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General MedicationsORALGeneric

FINGOLIMOD

FINGOLIMOD

Standard Dose
EQ 0.5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview FINGOLIMOD is listed in Drugs@FDA under application 207940 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient FINGOLIMOD Form and strength CAPSULE;ORAL - EQ 0.5MG BASE Sponsor STANDARD CHEM AND PHARM CO LTD Submission history Latest submission status date: 2021-05-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview FINGOLIMOD is listed in Drugs@FDA under application 207940 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient FINGOLIMOD Form and strength CAPSULE;ORAL - EQ 0.5MG BASE Sponsor STANDARD CHEM AND PHARM CO LTD Submission history Latest submission status date: 2021-05-11 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: None (Tentative Approval)
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.