← FDA DRUG APPROVALS

FDA NDA · NDA022352

COLCRYS

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022352
TYPE
NDA
ORIGINAL APPROVAL
2009-07-29
LATEST ACTION
2020-05-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

COLCRYS · ReferenceDiscontinued
COLCHICINE 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2020-05-14Labeling · Supplement 26 · standard — Letter ↗AP
2016-12-22Manufacturing (CMC) · Supplement 25 · standardAP
2016-01-25Manufacturing (CMC) · Supplement 23 · priorityAP
2015-12-17Labeling · Supplement 22 · standard — Medication Guide ↗AP
2014-08-14Labeling · Supplement 17 · unknown — Letter ↗AP
2013-11-25Manufacturing (CMC) · Supplement 21 · priorityAP
2013-05-15Manufacturing (CMC) · Supplement 19 · priorityAP
2011-07-20Labeling · Supplement 14 · unknown — Label ↗AP
2011-07-20REMS · Supplement 13 — Letter ↗AP
2010-04-29Labeling · Supplement 4 · unknown — Label ↗AP
2009-07-29Type 7 - Drug Already Marketed without Approved NDA · 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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