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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022581
Company: FRESENIUS MEDCL

Summary Review

Products on NDA 022581

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHOSLYRA	CALCIUM ACETATE	667MG/5ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022581

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2011	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022581s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022581s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022581_phoslyra_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022581Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022581s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022581Orig1s010ltr.pdf
04/30/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022581Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022581Orig1s006ltr.pdf
08/27/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/17/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/16/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022581

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022581s010lbl.pdf
04/30/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022581Orig1s006lbl.pdf
04/18/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022581s000lbl.pdf

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