APPLICATION
ANDA207624
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-13
LATEST ACTION
2022-04-05
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
2022-04-05Labeling · Supplement 3 · standardAP
2020-03-25Labeling · Supplement 1 · 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.
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