APPLICATION
ANDA070256
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-07
LATEST ACTION
2024-08-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2024-08-13Labeling · Supplement 18 · standardAP
2006-12-13Labeling · Supplement 9AP
1997-08-08Manufacturing (CMC) · Supplement 8AP
1993-04-27Labeling · Supplement 6AP
1991-07-11Manufacturing (CMC) · Supplement 2AP
1990-07-31Labeling · Supplement 4AP
1987-01-07OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.