APPLICATION
ANDA207846
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-17
LATEST ACTION
2025-08-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NALOXONE HYDROCHLORIDEDiscontinued
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2025-08-01Labeling · Supplement 1 · standardAP
2018-12-17UNKNOWN · Original · standardAP
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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