Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLEGISOL IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1982 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/12/2000 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1999 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18608slr031ltr.pdf |
| 03/20/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/09/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/13/1989 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |
PLEGISOL IN PLASTIC CONTAINER
SOLUTION;PERFUSION, CARDIAC; 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription | No | AT | 075323 | BAXTER HLTHCARE |
| CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription | No | AT | 214623 | FRESENIUS KABI USA |
| PLEGISOL IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | SOLUTION;PERFUSION, CARDIAC | Prescription | Yes | AT | 018608 | HOSPIRA |