← FDA DRUG APPROVALS

FDA NDA · NDA215457

NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR

naloxone hydrochloride

Sponsor: KALEO INC

APPLICATION
NDA215457
TYPE
NDA
ORIGINAL APPROVAL
2022-02-28
LATEST ACTION
2023-04-03
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 10MG/0.4ML (10MG/0.4ML) · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2023-04-03Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2022-02-28Type 5 - New Formulation or New Manufacturer · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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