APPLICATION
ANDA070496
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-22
LATEST ACTION
1987-12-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NALOXONEDiscontinued
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
1987-12-18Manufacturing (CMC) · Supplement 3AP
1987-12-18Manufacturing (CMC) · Supplement 1AP
1987-01-29Manufacturing (CMC) · Supplement 5AP
1986-12-19Manufacturing (CMC) · Supplement 4AP
1986-12-19Manufacturing (CMC) · Supplement 7AP
1986-11-03Manufacturing (CMC) · Supplement 6AP
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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