APPLICATION
ANDA213279
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-14
LATEST ACTION
2023-08-24
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2023-08-24Manufacturing (CMC) · Supplement 7 · unknownAP
2023-06-02Labeling · Supplement 5 · standardAP
2023-06-02Labeling · Supplement 3 · standardAP
2021-11-17Labeling · Supplement 2 · standardAP
2021-01-14UNKNOWN · 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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