Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219456
Company: FRESENIUS MEDCL CARE
Company: FRESENIUS MEDCL CARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALREZDY | CALCUIM CHLORIDE | 14.7G/L calcium chloride dihydrate (100MMOL/L calcium) | SOLUTION; INJECTION | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 10/19/2026 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219456oRIG1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219456Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/19/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219456oRIG1s000lbl.pdf |