APPLICATION
ANDA070191
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-02
LATEST ACTION
1989-10-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NALOXONEDiscontinued
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
1989-10-27Labeling · Supplement 7AP
1988-06-03Labeling · Supplement 5AP
1988-01-22Manufacturing (CMC) · Supplement 2AP
1987-06-05Manufacturing (CMC) · Supplement 4AP
1987-02-20Manufacturing (CMC) · Supplement 3AP
1985-10-02OriginalAP
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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