Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;149MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;224MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;298MG/100ML | INJECTABLE;INJECTION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 05/29/1980 | 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 |
|---|---|---|---|---|---|
| 09/08/2014 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2001 | SUPPL-73 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/26/1999 | SUPPL-72 | Labeling |
Label is not available on this site. |
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| 01/05/1999 | SUPPL-71 | Labeling |
Label is not available on this site. |
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| 02/01/1999 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1997 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/22/1997 | SUPPL-67 | Labeling |
Label is not available on this site. |
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| 08/06/1996 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1999 | SUPPL-65 | Labeling |
Label is not available on this site. |
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| 03/04/1996 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1995 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/29/1996 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1991 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1992 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1991 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1990 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1990 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/25/1988 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 05/25/1988 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/26/1986 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1986 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1986 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1985 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1986 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 05/03/1985 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1985 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/09/1984 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1984 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1985 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 11/29/1985 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/28/1984 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/09/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1984 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/21/1984 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/05/1983 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 07/05/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/17/1984 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/10/1984 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/10/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/07/1981 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1981 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/20/1981 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/08/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/08/1981 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/13/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |