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General MedicationsORALGeneric

LEGUBETI

ACETYLCYSTEINE LYSINE

Standard Dose
EQ 500MG BASE/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview LEGUBETI is listed in Drugs@FDA under application 215040 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETYLCYSTEINE LYSINE Form and strength FOR SOLUTION;ORAL - EQ 500MG BASE/PACKET Sponsor GALEPHAR Submission history Latest submission status date: 2024-02-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview LEGUBETI is listed in Drugs@FDA under application 215040 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETYLCYSTEINE LYSINE Form and strength FOR SOLUTION;ORAL - EQ 500MG BASE/PACKET Sponsor GALEPHAR Submission history Latest submission status date: 2024-02-13 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.