Phoslyra

NDA 22581, held by Fresenius Medcl Care. Calcium Acetate.

As of Nov 14, 2026, NDA 22581 (Phoslyra), held by Fresenius Medcl Care, was first approved by FDA on Apr 18, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 18, 2011
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 18, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phoslyra667MG/5ML · solution;oral	Calcium Acetate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Sep 30, 2020	Supplement 10Labeling · Standard review	Approved	Label Letter
Apr 30, 2015	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 27, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
May 16, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 17, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 18, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22581
Drugs@FDA: Overview at FDA
Company: Fresenius Medical Care

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters