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FDA NDA · NDA205787

EVZIO

Sponsor: KALEO INC

APPLICATION
NDA205787
TYPE
NDA
ORIGINAL APPROVAL
2014-04-03
LATEST ACTION
2016-06-23
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

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

Approval history

2016-06-23Manufacturing (CMC) · Supplement 6 · priorityAP
2016-06-06Manufacturing (CMC) · Supplement 3 · priorityAP
2015-05-11Manufacturing (CMC) · Supplement 2 · priorityAP
2014-04-03Type 3 - New Dosage Form and Type 4 - New Combination · Original · priority — Label ↗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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