APPLICATION
ANDA070172
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-18
LATEST ACTION
2023-05-31
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2023-05-31Labeling · Supplement 31 · standardAP
2004-02-23Labeling · Supplement 6AP
2001-02-14Manufacturing (CMC) · Supplement 4AP
1995-12-22Manufacturing (CMC) · Supplement 3AP
1993-04-26Manufacturing (CMC) · Supplement 2AP
1992-11-19Labeling · Supplement 1AP
1986-04-18OriginalAP
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.
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