APPLICATION
NDA018757
TYPE
NDA
ORIGINAL APPROVAL
1982-12-28
LATEST ACTION
2002-06-05
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
CALCIBINDDiscontinued
CELLULOSE SODIUM PHOSPHATE 300GM/BOT · POWDER · ORAL
CALCIBINDDiscontinued
CELLULOSE SODIUM PHOSPHATE 2.5GM/PACKET · POWDER · ORAL
Approval history
2002-06-05Manufacturing (CMC) · Supplement 10 · priorityAP
1999-07-30Manufacturing (CMC) · Supplement 8 · priorityAP
1999-05-28Manufacturing (CMC) · Supplement 7 · priorityAP
1999-02-11Manufacturing (CMC) · Supplement 6 · priorityAP
1996-06-14Manufacturing (CMC) · Supplement 5 · priorityAP
1988-12-23Manufacturing (CMC) · Supplement 4 · priorityAP
1988-07-08Labeling · Supplement 3AP
1984-10-16Labeling · Supplement 2AP
1984-04-10Manufacturing (CMC) · Supplement 1 · priorityAP
1982-12-28Type 1 - New Molecular Entity · Original · priorityAP
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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