APPLICATION
ANDA070298
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-22
LATEST ACTION
1999-11-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NALOXONEDiscontinued
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
1999-11-04Manufacturing (CMC) · Supplement 14AP
1999-01-11Manufacturing (CMC) · Supplement 12AP
1999-01-11Manufacturing (CMC) · Supplement 13AP
1996-08-26Manufacturing (CMC) · Supplement 11AP
1993-03-26Labeling · Supplement 9AP
1991-01-16Labeling · Supplement 7AP
1991-01-16Labeling · Supplement 6AP
1987-01-29Manufacturing (CMC) · Supplement 1AP
1987-01-29Manufacturing (CMC) · Supplement 2AP
1986-12-19Manufacturing (CMC) · Supplement 4AP
1985-10-22OriginalAP
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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