APPLICATION
ANDA216624
TYPE
ANDA
ORIGINAL APPROVAL
2022-10-26
LATEST ACTION
2025-06-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2025-06-26Manufacturing (CMC) · Supplement 4 · unknownAP
2023-05-15Labeling · Supplement 1 · standardAP
2022-10-26UNKNOWN · 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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