General MedicationsNASALGeneric

NALOXONE HYDROCHLORIDE

Standard Dose

8MG/SPRAY

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 216719 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient NALOXONE HYDROCHLORIDE Form and strength SPRAY;NASAL - 8MG/SPRAY Sponsor PADAGIS ISRAEL Submission history Latest submission status date: 2025-04-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 216719 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient NALOXONE HYDROCHLORIDE Form and strength SPRAY;NASAL - 8MG/SPRAY Sponsor PADAGIS ISRAEL Submission history Latest submission status date: 2025-04-24 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.