Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018362
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 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None Yes 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-95 Manufacturing (CMC)

Label is not available on this site.

07/18/2002 SUPPL-71 Labeling

Label is not available on this site.

05/27/1999 SUPPL-70 Labeling

Label is not available on this site.

01/21/1999 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-68 Manufacturing (CMC)

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)

Label is not available on this site.

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

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)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

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)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

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)

Label is not available on this site.

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

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)

Label is not available on this site.

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

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)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

08/31/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

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)

Label is not available on this site.

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

Label is not available on this site.

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

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)

Label is not available on this site.

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

Label is not available on this site.

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.

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.

06/12/1981 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)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

INJECTABLE;INJECTION; 5GM/100ML;74.5MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;298MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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