APPLICATION
NDA016640
TYPE
NDA
ORIGINAL APPROVAL
1973-08-03
LATEST ACTION
1997-08-22
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
QUESTRAN · ReferenceDiscontinued
CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · ORAL
QUESTRAN · 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CHOLESTYRAMINE EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · ORAL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
1997-08-22Labeling · Supplement 74 · standardAP
1995-09-22Labeling · Supplement 68 · standardAP
1995-09-22Labeling · Supplement 69 · standardAP
1994-12-12Labeling · Supplement 70 · standardAP
1994-12-12Labeling · Supplement 71 · standardAP
1994-12-07Labeling · Supplement 33 · standardAP
1993-01-07Manufacturing (CMC) · Supplement 67 · standardAP
1992-09-22Manufacturing (CMC) · Supplement 65 · standardAP
1992-08-11Labeling · Supplement 66 · standardAP
1991-10-24Labeling · Supplement 60 · standardAP
1991-09-10Labeling · Supplement 63 · standardAP
1991-03-06Manufacturing (CMC) · Supplement 57 · standardAP
1990-05-25Manufacturing (CMC) · Supplement 59 · standardAP
1990-03-05Manufacturing (CMC) · Supplement 58 · standardAP
1990-02-02Manufacturing (CMC) · Supplement 56 · standardAP
1990-01-22Manufacturing (CMC) · Supplement 54 · standardAP
1989-11-28Labeling · Supplement 55 · standardAP
1989-03-02Manufacturing (CMC) · Supplement 42 · standardAP
1989-02-23Manufacturing (CMC) · Supplement 50 · standardAP
1988-12-01Manufacturing (CMC) · Supplement 49 · standardAP
1988-10-11Manufacturing (CMC) · Supplement 48 · standardAP
1988-08-26Manufacturing (CMC) · Supplement 46 · standardAP
1988-08-26Manufacturing (CMC) · Supplement 47 · standardAP
1988-07-14Manufacturing (CMC) · Supplement 44 · standardAP
1988-07-14Manufacturing (CMC) · Supplement 45 · standardAP
1988-07-14Manufacturing (CMC) · Supplement 43 · standardAP
1988-06-29Manufacturing (CMC) · Supplement 40 · standardAP
1988-03-25Manufacturing (CMC) · Supplement 39 · standardAP
1988-03-18Manufacturing (CMC) · Supplement 38 · standardAP
1988-02-16Manufacturing (CMC) · Supplement 36 · standardAP
1988-01-05Manufacturing (CMC) · Supplement 37 · standardAP
1987-11-19Manufacturing (CMC) · Supplement 34 · standardAP
1987-11-19Manufacturing (CMC) · Supplement 35 · standardAP
1987-09-18Manufacturing (CMC) · Supplement 30 · standardAP
1986-09-19Manufacturing (CMC) · Supplement 26 · standardAP
1986-03-12Manufacturing (CMC) · Supplement 25 · standardAP
1986-02-25Labeling · Supplement 27 · standardAP
1986-01-24Manufacturing (CMC) · Supplement 28 · standardAP
1985-11-26Manufacturing (CMC) · Supplement 23 · standardAP
1985-11-01Manufacturing (CMC) · Supplement 22 · 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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