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FDA NDA · NDA210895

WELCHOL

Sponsor: COSETTE

APPLICATION
NDA210895
TYPE
NDA
ORIGINAL APPROVAL
2019-04-03
LATEST ACTION
2020-05-12
ROUTE
ORAL
DOSAGE FORM
BAR, CHEWABLE
MARKETING STATUS
Discontinued

Products

WELCHOL · ReferenceDiscontinued
COLESEVELAM HYDROCHLORIDE 3.75GM · BAR, CHEWABLE · ORAL

Approval history

2020-05-12Labeling · Supplement 1 · standard — Letter ↗AP
2019-04-03Type 3 - New Dosage Form · Original · standard — 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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