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General MedicationsORALStandard

TIROSINT-SOL

LEVOTHYROXINE SODIUM

Standard Dose
13MCG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TIROSINT-SOL is listed in Drugs@FDA under application 206977 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LEVOTHYROXINE SODIUM Form and strength SOLUTION;ORAL - 13MCG/ML Sponsor IBSA Submission history Latest submission status date: 2023-11-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview TIROSINT-SOL is listed in Drugs@FDA under application 206977 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEVOTHYROXINE SODIUM Form and strength SOLUTION;ORAL - 13MCG/ML Sponsor IBSA Submission history Latest submission status date: 2023-11-16 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.