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General MedicationsNASALStandard

REZENOPY

NALOXONE HYDROCHLORIDE

Standard Dose
10MG/SPRAY
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview REZENOPY is listed in Drugs@FDA under application 215487 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NALOXONE HYDROCHLORIDE Form and strength SPRAY;NASAL - 10MG/SPRAY Sponsor SCIENTURE Submission history Latest submission status date: 2024-04-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview REZENOPY is listed in Drugs@FDA under application 215487 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NALOXONE HYDROCHLORIDE Form and strength SPRAY;NASAL - 10MG/SPRAY Sponsor SCIENTURE Submission history Latest submission status date: 2024-04-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.