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FDA NDA · NDA022450

OFIRMEV

Sponsor: MALLINCKRODT HOSP

APPLICATION
NDA022450
TYPE
NDA
ORIGINAL APPROVAL
2010-11-02
LATEST ACTION
2018-04-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

OFIRMEV · ReferenceDiscontinued
ACETAMINOPHEN 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2018-04-06Labeling · Supplement 11 · standard — Letter ↗AP
2017-01-27Efficacy · Supplement 10 · priority — Label ↗AP
2013-10-18Labeling · Supplement 6 · standard — Label ↗AP
2013-10-18Labeling · Supplement 5 · standard — Label ↗AP
2013-04-19Manufacturing (CMC) · Supplement 4 · priorityAP
2013-04-05Manufacturing (CMC) · Supplement 3 · priorityAP
2010-11-02Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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