← FDA DRUG APPROVALS

FDA NDA · NDA022362

WELCHOL

Sponsor: COSETTE

APPLICATION
NDA022362
TYPE
NDA
ORIGINAL APPROVAL
2009-10-02
LATEST ACTION
2021-10-20
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued, Prescription

Products

WELCHOL · ReferenceDiscontinued
COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
WELCHOL · ReferencePrescription
COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET · FOR SUSPENSION · ORAL

Approval history

2021-10-20Efficacy · Supplement 29 · standard — Label ↗AP
2020-07-29Labeling · Supplement 28 · standard — Letter ↗AP
2020-05-12Labeling · Supplement 27 · standard — Letter ↗AP
2019-05-21Labeling · Supplement 25 · standard — Label ↗AP
2019-04-10Labeling · Supplement 24 · standard — Letter ↗AP
2019-01-16Labeling · Supplement 23 · standard — Label ↗AP
2014-03-11Manufacturing (CMC) · Supplement 19 · standardAP
2014-01-22Labeling · Supplement 20 · standard — Label ↗AP
2013-06-28Labeling · Supplement 18 · standard — Label ↗AP
2013-06-28Labeling · Supplement 17 · standard — Label ↗AP
2013-06-28Manufacturing (CMC) · Supplement 15 — Label ↗AP
2013-03-07Manufacturing (CMC) · Supplement 16 · standardAP
2013-02-27Manufacturing (CMC) · Supplement 14 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 13 · standardAP
2012-11-15Manufacturing (CMC) · Supplement 12 · standardAP
2012-07-09Labeling · Supplement 10 · standard — Label ↗AP
2012-01-03Labeling · Supplement 9 · standard — Label ↗AP
2011-07-18Labeling · Supplement 7 · standard — Label ↗AP
2010-09-14Labeling · Supplement 2 · unknown — Label ↗AP
2009-10-02Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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