Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019416
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/1986 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-32 Manufacturing (CMC)

Label is not available on this site.

08/21/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/13/1999 SUPPL-15 Labeling

Label is not available on this site.

08/27/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/14/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/22/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/13/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LACTATED RINGER'S IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription Yes AT 018681 B BRAUN
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription No AT 018494 BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription Yes AT 018921 BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription Yes AT 019416 ICU MEDICAL INC

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