APPLICATION
ANDA208871
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-28
LATEST ACTION
2023-07-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2023-07-12Labeling · Supplement 1 · standardAP
2023-07-12Labeling · Supplement 4 · 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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