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FDA NDA · NDA020926

RENAGEL

Sponsor: GENZYME

APPLICATION
NDA020926
TYPE
NDA
ORIGINAL APPROVAL
1998-10-30
LATEST ACTION
2004-02-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

RENAGELDiscontinued
SEVELAMER HYDROCHLORIDE 403MG · CAPSULE · ORAL

Approval history

2004-02-06Efficacy · Supplement 6 · standard — Letter ↗AP
2002-08-08Manufacturing (CMC) · Supplement 5 · standardAP
2002-03-15Manufacturing (CMC) · Supplement 4 · standardAP
2000-10-13Manufacturing (CMC) · Supplement 3 · standardAP
2000-05-05Efficacy · Supplement 2 · standard — Letter ↗AP
1999-10-01Manufacturing (CMC) · Supplement 1 · standardAP
1998-10-30Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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