APPLICATION
ANDA213843
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-09
LATEST ACTION
2025-01-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2025-01-16Labeling · Supplement 6 · standardAP
2022-06-09UNKNOWN · 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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