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General MedicationsORALGeneric

MACRILEN

MACIMORELIN ACETATE

Standard Dose
EQ 60MG BASE/POUCH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview MACRILEN is listed in Drugs@FDA under application 205598 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient MACIMORELIN ACETATE Form and strength FOR SOLUTION;ORAL - EQ 60MG BASE/POUCH Sponsor AETERNA ZENTARIS Submission history Latest submission status date: 2019-11-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview MACRILEN is listed in Drugs@FDA under application 205598 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient MACIMORELIN ACETATE Form and strength FOR SOLUTION;ORAL - EQ 60MG BASE/POUCH Sponsor AETERNA ZENTARIS Submission history Latest submission status date: 2019-11-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.