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

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

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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