APPLICATION
ANDA211917
TYPE
ANDA
ORIGINAL APPROVAL
2023-09-08
LATEST ACTION
2023-09-08
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
SEVELAMER CARBONATEPrescription
SEVELAMER CARBONATE 800MG/PACKET · FOR SUSPENSION · ORAL
SEVELAMER CARBONATEPrescription
SEVELAMER CARBONATE 2.4GM/PACKET · FOR SUSPENSION · ORAL
Approval history
2023-09-08UNKNOWN · Original · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.