← FDA DRUG APPROVALS

FDA NDA · NDA204734

FOSRENOL

lanthanum carbonate

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA204734
TYPE
NDA
ORIGINAL APPROVAL
2014-09-24
LATEST ACTION
2024-08-29
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

FOSRENOL · ReferencePrescription
LANTHANUM CARBONATE EQ 1GM BASE · POWDER · ORAL
FOSRENOL · ReferencePrescription
LANTHANUM CARBONATE EQ 750MG BASE · POWDER · ORAL

Approval history

2024-08-29Labeling · Supplement 7 · standard — Label ↗AP
2023-12-12Labeling · Supplement 6 · standard — Letter ↗AP
2023-05-10Labeling · Supplement 8 · standard — Label ↗AP
2020-05-11Labeling · Supplement 5 · standard — Letter ↗AP
2018-11-08Labeling · Supplement 3 · standard — Label ↗AP
2016-02-24Labeling · Supplement 1 · standard — Letter ↗AP
2014-09-24Type 3 - New Dosage Form · Original · standard — Letter ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →