APPLICATION
ANDA077510
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-24
LATEST ACTION
2026-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
COLESTIPOL HYDROCHLORIDEPrescription
COLESTIPOL HYDROCHLORIDE 1GM · TABLET · ORAL
Approval history
2026-04-15Labeling · Supplement 31 · standardAP
2026-04-15Labeling · Supplement 28 · standardAP
2026-04-15Labeling · Supplement 14 · standardAP
2014-10-09Manufacturing (CMC) · Supplement 8AP
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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