Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018365
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;225MG/100ML INJECTABLE;INJECTION Prescription None Yes No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
09/05/2013 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

08/24/2001 SUPPL-70 Labeling

Label is not available on this site.

01/22/1999 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1998 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-65 Labeling

Label is not available on this site.

08/06/1996 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1995 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1991 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/28/1988 SUPPL-49 Labeling

Label is not available on this site.

03/28/1988 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1985 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-40 Labeling

Label is not available on this site.

05/03/1985 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1984 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1985 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1985 SUPPL-31 Labeling

Label is not available on this site.

11/29/1985 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1985 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1989 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1983 SUPPL-23 Labeling

Label is not available on this site.

07/05/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1983 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1984 SUPPL-19 Labeling

Label is not available on this site.

10/10/1984 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-16 Manufacturing (CMC)-Control

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)-Control

Label is not available on this site.

07/08/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1981 SUPPL-8 Labeling

Label is not available on this site.

06/20/1981 SUPPL-6 Labeling

Label is not available on this site.

04/08/1981 SUPPL-5 Labeling

Label is not available on this site.

04/08/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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