← FDA DRUG APPROVALS

FDA ANDA · ANDA205014

NALOXONE HYDROCHLORIDE

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
ANDA205014
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-29
LATEST ACTION
2016-06-29
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION

Approval history

2016-06-29UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →