General MedicationsINJECTIONStandard
NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE
Standard Dose
1MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 216977 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient NALOXONE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 1MG/ML Sponsor BPI LABS Submission history Latest submission status date: 2024-11-02 00:00:00.
Structured Monograph
Clinical summary
Approval overview NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 216977 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NALOXONE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 1MG/ML Sponsor BPI LABS Submission history Latest submission status date: 2024-11-02 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.