APPLICATION
ANDA073263
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-22
LATEST ACTION
2002-12-19
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
PREVALITEPrescription
CHOLESTYRAMINE EQ 4GM RESIN/PACKET · POWDER · ORAL
PREVALITEPrescription
CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL · POWDER · ORAL
Approval history
2002-12-19Manufacturing (CMC) · Supplement 12AP
1999-10-29Manufacturing (CMC) · Supplement 11AP
1999-08-27Manufacturing (CMC) · Supplement 8AP
1999-08-27Labeling · Supplement 10AP
1999-08-27Manufacturing (CMC) · Supplement 9AP
1998-02-20Labeling · Supplement 7AP
1997-10-30Manufacturing (CMC) · Supplement 4AP
1997-10-30Labeling · Supplement 5AP
1996-08-21Manufacturing (CMC) · Supplement 2AP
1996-06-24Manufacturing (CMC) · Supplement 1AP
1996-02-22OriginalAP
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.