Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022581
Company: FRESENIUS MEDCL
Company: FRESENIUS MEDCL
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 |
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. |
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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 |
---|---|---|---|---|---|
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 |