APPLICATION
ANDA074557
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-15
LATEST ACTION
2024-12-26
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
CHOLESTYRAMINEPrescription
CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL · POWDER · ORAL
CHOLESTYRAMINEPrescription
CHOLESTYRAMINE EQ 4GM RESIN/PACKET · POWDER · ORAL
Approval history
2024-12-26Manufacturing (CMC) · Supplement 16 · unknownAP
2000-02-02Manufacturing (CMC) · Supplement 5AP
1998-05-27Manufacturing (CMC) · Supplement 2AP
1998-05-27Manufacturing (CMC) · Supplement 3AP
1998-02-13Labeling · Supplement 4AP
1996-10-08Labeling · Supplement 1AP
1996-08-15OriginalAP
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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