General MedicationsINTRAVENOUSGeneric
ZULRESSO
BREXANOLONE
Standard Dose
100MG/20ML (5MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Discontinued
Summary
Approval overview ZULRESSO is listed in Drugs@FDA under application 211371 (NDA).
Review priority: N/A Marketing status: Discontinued Active ingredient BREXANOLONE Form and strength SOLUTION;INTRAVENOUS - 100MG/20ML (5MG/ML) Sponsor SAGE THERAP Submission history Latest submission status date: 2025-01-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview ZULRESSO is listed in Drugs@FDA under application 211371 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient BREXANOLONE Form and strength SOLUTION;INTRAVENOUS - 100MG/20ML (5MG/ML) Sponsor SAGE THERAP Submission history Latest submission status date: 2025-01-23 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: N/A
Interaction Notes
- No interaction notes stored yet.