APPLICATION
ANDA203860
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-26
LATEST ACTION
2020-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SEVELAMER CARBONATEPrescription
SEVELAMER CARBONATE 800MG · TABLET · ORAL
Approval history
2020-12-28Labeling · Supplement 9 · standardAP
2020-04-10Manufacturing (CMC) · Supplement 6 · unknownAP
2017-10-26UNKNOWN · OriginalAP
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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