Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019976
Company: FRESENIUS MEDCL
Company: FRESENIUS MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHOSLO | CALCIUM ACETATE | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/10/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/09/2016 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf |
| 11/04/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19976slr005ltr.pdf |
| 05/07/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |