← FDA DRUG APPROVALS

FDA ANDA · ANDA088786

SODIUM POLYSTYRENE SULFONATE

Sponsor: PAI HOLDINGS PHARM

APPLICATION
ANDA088786
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-11
LATEST ACTION
1991-11-08
ROUTE
ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

SODIUM POLYSTYRENE SULFONATE · ReferenceDiscontinued
SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT · POWDER · ORAL, RECTAL

Approval history

1991-11-08Labeling · Supplement 6AP
1990-01-30Labeling · Supplement 5AP
1989-08-29Labeling · Supplement 4AP
1987-03-06Manufacturing (CMC) · Supplement 2AP
1987-03-06Manufacturing (CMC) · Supplement 3AP
1986-05-23Manufacturing (CMC) · Supplement 1AP
1984-09-11OriginalAP
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 →