APPLICATION
ANDA212456
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-04
LATEST ACTION
2019-11-04
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION
Approval history
2019-11-04UNKNOWN · 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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