Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019686
Company: ICU MEDICAL INC

Products on NDA 019686

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	149MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	298MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019686

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/1988	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
09/10/2015	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
09/08/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
05/19/1999	SUPPL-11	Labeling		Label is not available on this site.
08/06/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/14/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/29/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/27/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/28/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/10/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/11/1990	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/22/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 019686

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 149MG/100ML;900MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	149MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019686	ICU MEDICAL INC

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 298MG/100ML;900MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	298MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019686	ICU MEDICAL INC