General MedicationsINTRAVENOUSStandard
NUZYRA
OMADACYCLINE TOSYLATE
Standard Dose
EQ 100MG BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview NUZYRA is listed in Drugs@FDA under application 209817 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient OMADACYCLINE TOSYLATE Form and strength POWDER;INTRAVENOUS - EQ 100MG BASE/VIAL Sponsor PARATEK PHARMS Submission history Latest submission status date: 2025-03-31 00:00:00.
Structured Monograph
Clinical summary
Approval overview NUZYRA is listed in Drugs@FDA under application 209817 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMADACYCLINE TOSYLATE Form and strength POWDER;INTRAVENOUS - EQ 100MG BASE/VIAL Sponsor PARATEK PHARMS Submission history Latest submission status date: 2025-03-31 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.