Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022581
Company: FRESENIUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHOSLYRA CALCIUM ACETATE 667MG/5ML SOLUTION;ORAL Prescription None Yes Yes
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
04/30/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022581s006lbl.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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022581s006lbl.pdf
04/18/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022581s000lbl.pdf

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