APPLICATION
ANDA070253
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-16
LATEST ACTION
1998-04-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NALOXONE HYDROCHLORIDEDiscontinued
NALOXONE HYDROCHLORIDE 0.02MG/ML · INJECTABLE · INJECTION
Approval history
1998-04-08Manufacturing (CMC) · Supplement 9AP
1993-04-27Labeling · Supplement 7AP
1991-07-11Manufacturing (CMC) · Supplement 2AP
1991-04-26Labeling · Supplement 5AP
1990-07-31Labeling · Supplement 4AP
1987-01-16OriginalAP
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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