APPLICATION
NDA019669
TYPE
NDA
ORIGINAL APPROVAL
1988-12-05
LATEST ACTION
2000-03-20
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
QUESTRAN LIGHT · ReferenceDiscontinued
CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · ORAL
QUESTRAN LIGHT · ReferenceDiscontinued
CHOLESTYRAMINE EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · ORAL
Approval history
2000-03-20Labeling · Supplement 24 · standardAP
1997-10-29Manufacturing (CMC) · Supplement 23 · standardAP
1997-08-22Labeling · Supplement 22 · standardAP
1995-09-22Labeling · Supplement 17 · standardAP
1995-09-22Labeling · Supplement 18 · standardAP
1994-12-12Labeling · Supplement 19 · standardAP
1993-01-07Manufacturing (CMC) · Supplement 16 · standardAP
1992-09-22Manufacturing (CMC) · Supplement 14 · standardAP
1992-08-11Labeling · Supplement 15 · standardAP
1991-09-10Labeling · Supplement 12 · standardAP
1991-03-12Manufacturing (CMC) · Supplement 9 · standardAP
1990-02-02Manufacturing (CMC) · Supplement 8 · standardAP
1989-11-27Labeling · Supplement 7 · standardAP
1989-02-21Manufacturing (CMC) · Supplement 2 · standardAP
1989-02-21Manufacturing (CMC) · Supplement 3 · standardAP
1989-02-21Manufacturing (CMC) · Supplement 1 · standardAP
1988-12-05Type 3 - New Dosage Form · Original · 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.
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