Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018365
Company: ICU MEDICAL INC

Products on NDA 018365

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CHLORIDE	5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No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SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No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SODIUM CHLORIDE	5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No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	AP	Yes	Yes
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SODIUM CHLORIDE	5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No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SODIUM CHLORIDE	5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No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SODIUM CHLORIDE	5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018365

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.

Therapeutic Equivalents for NDA 018365

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;225MG/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 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212348	FRESENIUS KABI USA
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	No	AP	212348	FRESENIUS KABI USA
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	Yes	AP	018365	ICU MEDICAL INC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.