APPLICATION
ANDA215964
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-29
LATEST ACTION
2025-06-04
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2025-06-04Labeling · Supplement 7 · standardAP
2023-10-05Labeling · Supplement 3 · standardAP
2023-05-16Labeling · Supplement 1 · standardAP
2022-07-29UNKNOWN · 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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