Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019685
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 LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/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
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
08/15/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/08/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/27/2001 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/19/1999 SUPPL-12 Labeling

Label is not available on this site.

08/06/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 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 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019685 ICU MEDICAL INC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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