← FDA DRUG APPROVALS

FDA NDA · NDA212854

ZIMHI

naloxone hydrochloride

Sponsor: ZMI PHARMA

APPLICATION
NDA212854
TYPE
NDA
ORIGINAL APPROVAL
2021-10-15
LATEST ACTION
2021-10-15
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ZIMHI · ReferencePrescription
NALOXONE HYDROCHLORIDE 5MG/0.5ML (5MG/0.5ML) · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2021-10-15Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →