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FDA NDA · NDA022581

PHOSLYRA

Sponsor: FRESENIUS MEDCL CARE

APPLICATION
NDA022581
TYPE
NDA
ORIGINAL APPROVAL
2011-04-18
LATEST ACTION
2020-09-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PHOSLYRA · ReferenceDiscontinued
CALCIUM ACETATE 667MG/5ML · SOLUTION · ORAL

Approval history

2020-09-30Labeling · Supplement 10 · standard — Letter ↗AP
2015-04-30Labeling · Supplement 6 · standard — Label ↗AP
2014-08-27Manufacturing (CMC) · Supplement 5 · standardAP
2014-05-16Manufacturing (CMC) · Supplement 2 · standardAP
2014-01-17Manufacturing (CMC) · Supplement 4 · standardAP
2011-04-18Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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