Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021160
Company: FRESENIUS MEDCL
Company: FRESENIUS MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHOSLO | CALCIUM ACETATE | 333.5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PHOSLO | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PHOSLO GELCAPS | CALCIUM ACETATE | 667MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/02/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021160_Phoslo.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/22/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2011 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021160s015ltr.pdf | |
| 02/02/2004 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/29/2011 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf | |
| 04/02/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf |