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FDA NDA · NDA022127

SEVELAMER CARBONATE

Sponsor: SANOFI

APPLICATION
NDA022127
TYPE
NDA
ORIGINAL APPROVAL
2007-10-19
LATEST ACTION
2023-06-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RENVELA · ReferenceDiscontinued
SEVELAMER CARBONATE 800MG · TABLET · ORAL

Approval history

2023-06-06Labeling · Supplement 21 · standard — Label ↗AP
2020-04-30Labeling · Supplement 19 · standard — Letter ↗AP
2016-11-25Efficacy · Supplement 15 · priority — Letter ↗AP
2016-03-09Labeling · Supplement 13 · standard — Label ↗AP
2014-11-26Labeling · Supplement 11 · standard — Letter ↗AP
2011-06-16Labeling · Supplement 8 · unknown — Label ↗AP
2007-10-19Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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