← FDA DRUG APPROVALS

FDA NDA · NDA021468

FOSRENOL

lanthanum carbonate

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021468
TYPE
NDA
ORIGINAL APPROVAL
2004-10-26
LATEST ACTION
2024-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription, Discontinued

Products

FOSRENOL · ReferencePrescription
LANTHANUM CARBONATE EQ 500MG BASE · TABLET, CHEWABLE · ORAL
FOSRENOL · ReferencePrescription
LANTHANUM CARBONATE EQ 750MG BASE · TABLET, CHEWABLE · ORAL
FOSRENOLDiscontinued
LANTHANUM CARBONATE EQ 250MG BASE · TABLET, CHEWABLE · ORAL
FOSRENOL · ReferencePrescription
LANTHANUM CARBONATE EQ 1GM BASE · TABLET, CHEWABLE · ORAL

Approval history

2024-08-29Labeling · Supplement 25 · standard — Label ↗AP
2023-12-12Labeling · Supplement 24 · standard — Letter ↗AP
2023-05-10Labeling · Supplement 26 · standard — Label ↗AP
2020-05-11Labeling · Supplement 23 · standard — Letter ↗AP
2018-11-08Labeling · Supplement 21 · standard — Label ↗AP
2016-02-24Labeling · Supplement 20 · standard — Letter ↗AP
2014-09-24Labeling · Supplement 19 · standard — Label ↗AP
2012-10-31Labeling · Supplement 18 · unknown — Label ↗AP
2011-09-02Labeling · Supplement 16 · unknown — Letter ↗AP
2011-04-27Labeling · Supplement 15 · unknown — Label ↗AP
2011-04-27Labeling · Supplement 14 · unknown — Letter ↗AP
2008-10-23Labeling · Supplement 11 · standard — Letter ↗AP
2008-10-02Manufacturing (CMC) · Supplement 12AP
2008-04-10Labeling · Supplement 10 · standard — Letter ↗AP
2006-03-03Labeling · Supplement 4 · standard — Review ↗AP
2006-03-03Labeling · Supplement 5 · standard — Review ↗AP
2004-10-26Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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