APPLICATION
ANDA089049
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-17
LATEST ACTION
2012-10-19
ROUTE
ORAL, RECTAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
SODIUM POLYSTYRENE SULFONATEDiscontinued
SODIUM POLYSTYRENE SULFONATE 15GM/60ML · SUSPENSION · ORAL, RECTAL
Approval history
2012-10-19Labeling · Supplement 39 · standardAP
2005-08-03Labeling · Supplement 34AP
2002-03-18Manufacturing (CMC) · Supplement 29AP
2002-03-07Manufacturing (CMC) · Supplement 27AP
2001-05-03Manufacturing (CMC) · Supplement 30AP
2000-05-31Manufacturing (CMC) · Supplement 28AP
1998-03-31Manufacturing (CMC) · Supplement 25AP
1998-03-31Manufacturing (CMC) · Supplement 23AP
1998-03-31Manufacturing (CMC) · Supplement 21AP
1998-03-31Labeling · Supplement 26AP
1998-03-31Manufacturing (CMC) · Supplement 24AP
1998-03-31Manufacturing (CMC) · Supplement 22AP
1996-08-28Manufacturing (CMC) · Supplement 20AP
1995-11-14Manufacturing (CMC) · Supplement 19AP
1994-08-15Manufacturing (CMC) · Supplement 18AP
1993-12-16Manufacturing (CMC) · Supplement 16AP
1993-08-27Labeling · Supplement 17AP
1992-08-11Labeling · Supplement 15AP
1992-03-16Labeling · Supplement 14AP
1991-05-02Manufacturing (CMC) · Supplement 11AP
1991-05-02Labeling · Supplement 12AP
1991-05-02Manufacturing (CMC) · Supplement 10AP
1991-05-02Labeling · Supplement 9AP
1988-09-02Manufacturing (CMC) · Supplement 7AP
1988-09-02Manufacturing (CMC) · Supplement 6AP
1988-05-03Manufacturing (CMC) · Supplement 3AP
1988-05-03Manufacturing (CMC) · Supplement 1AP
1988-05-03Manufacturing (CMC) · Supplement 2AP
1986-11-17OriginalAP
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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