Drugs@FDA: FDA-Approved Drugs

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

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

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