← FDA DRUG APPROVALS

FDA NDA · NDA022041

CYANOKIT

hydroxocobalamin

Sponsor: BTG INTL

APPLICATION
NDA022041
TYPE
NDA
ORIGINAL APPROVAL
2006-12-15
LATEST ACTION
2018-12-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

CYANOKIT · ReferencePrescription
HYDROXOCOBALAMIN 5GM/VIAL (5GM/KIT) · INJECTABLE · INJECTION
CYANOKITDiscontinued
HYDROXOCOBALAMIN 2.5GM/VIAL (5GM/KIT) · INJECTABLE · INJECTION

Approval history

2018-12-31Labeling · Supplement 19 · standard — Label ↗AP
2018-12-31Labeling · Supplement 20 · standard — Label ↗AP
2016-02-04Manufacturing (CMC) · Supplement 1 · priorityAP
2016-02-04Manufacturing (CMC) · Supplement 16 · priorityAP
2014-07-03Manufacturing (CMC) · Supplement 15 · priorityAP
2013-11-21Manufacturing (CMC) · Supplement 13 · priorityAP
2011-04-08Labeling · Supplement 9 · standard — Label ↗AP
2011-04-08Labeling · Supplement 8 · priority — Label ↗AP
2010-10-13Labeling · Supplement 4 · standard — Label ↗AP
2010-02-19Labeling · Supplement 7 · unknown — Label ↗AP
2009-06-04Labeling · Supplement 5 · standard — Label ↗AP
2006-12-15Type 3 - New Dosage Form · 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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