← FDA DRUG APPROVALS

FDA ANDA · ANDA074554

CHOLESTYRAMINE

Sponsor: ANI PHARMS

APPLICATION
ANDA074554
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-02
LATEST ACTION
2000-05-31
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

CHOLESTYRAMINEDiscontinued
CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL · POWDER · ORAL
CHOLESTYRAMINEDiscontinued
CHOLESTYRAMINE EQ 4GM RESIN/PACKET · POWDER · ORAL

Approval history

2000-05-31Manufacturing (CMC) · Supplement 6AP
1999-07-30Manufacturing (CMC) · Supplement 5AP
1999-03-23Manufacturing (CMC) · Supplement 4AP
1998-12-01Manufacturing (CMC) · Supplement 3AP
1998-02-18Labeling · Supplement 2AP
1997-10-17Manufacturing (CMC) · Supplement 1AP
1996-10-02OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →