APPLICATION
ANDA070639
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-17
LATEST ACTION
2023-05-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NALOXONE HYDROCHLORIDEDiscontinued
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2023-05-18Labeling · Supplement 19 · standardAP
2015-05-29Manufacturing (CMC) · Supplement 16AP
2013-07-26Labeling · Supplement 17 · standardAP
2002-07-18Manufacturing (CMC) · Supplement 13AP
2002-07-18Labeling · Supplement 14AP
1998-01-14Manufacturing (CMC) · Supplement 8AP
1996-06-10Labeling · Supplement 12AP
1995-09-19Manufacturing (CMC) · Supplement 11AP
1995-02-09Labeling · Supplement 10AP
1994-06-17Manufacturing (CMC) · Supplement 9AP
1993-10-29Manufacturing (CMC) · Supplement 7AP
1988-05-20Labeling · Supplement 4AP
1987-02-06Manufacturing (CMC) · Supplement 3AP
1986-09-09Labeling · Supplement 2AP
1986-02-24Manufacturing (CMC) · Supplement 1AP
1986-01-17OriginalAP
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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