WELCHOL (COLESEVELAM HYDROCHLORIDE)
Summary
FDA approved WELCHOL (COLESEVELAM HYDROCHLORIDE) by COSETTE. NDA (New Drug) approval (Efficacy) on 2021-10-20. FOR SUSPENSION, ORAL.
Details
Source
Drug Approval
External ID
NDA022362-29
Action Date
2021-10-20
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
WELCHOL (generic: COLESEVELAM HYDROCHLORIDE), FOR SUSPENSION, ORAL. Application: NDA022362
Company
Context & Analysis
COSETTE has 4 FDA actions in our database.
Frequently Asked Questions
How often does COSETTE have FDA actions?
COSETTE has 4 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA022362-29" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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