Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHYSIOSOL IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | SOLUTION;IRRIGATION | 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 |
|---|---|---|---|---|---|---|---|
| 02/08/1978 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/2014 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1999 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/12/1998 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/25/1988 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1986 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1984 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1984 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/01/1980 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/08/1980 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1979 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1978 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |