← FDA DRUG APPROVALS

FDA ANDA · ANDA205727

SODIUM POLYSTYRENE SULFONATE

Sponsor: AJENAT PHARMS

APPLICATION
ANDA205727
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-23
LATEST ACTION
2018-03-16
ROUTE
ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

SODIUM POLYSTYRENE SULFONATEPrescription
SODIUM POLYSTYRENE SULFONATE 454GM/BOT · POWDER · ORAL, RECTAL

Approval history

2018-03-16Labeling · Supplement 1 · standardAP
2016-02-23UNKNOWN · Original · standardAP
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 →