APPLICATION
ANDA091600
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-16
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
COLESEVELAM HYDROCHLORIDEPrescription
COLESEVELAM HYDROCHLORIDE 625MG · TABLET · ORAL
Approval history
2024-10-11Labeling · Supplement 17 · standardAP
2024-10-11Labeling · Supplement 13 · standardAP
2024-10-11Labeling · Supplement 8 · standardAP
2024-10-11Labeling · Supplement 12 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.