Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017608
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP 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
08/13/1975 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
12/24/2015 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

08/15/2014 SUPPL-139 Manufacturing (CMC)

Label is not available on this site.

09/08/2014 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-116 Labeling

Label is not available on this site.

12/01/1998 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

10/12/1999 SUPPL-113 Labeling

Label is not available on this site.

08/06/1996 SUPPL-112 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-109 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

09/30/1985 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

08/27/1985 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-86 Labeling

Label is not available on this site.

05/03/1985 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

11/09/1984 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-77 Labeling

Label is not available on this site.

11/29/1985 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

11/28/1984 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

08/31/1988 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

10/25/1983 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

03/15/1985 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-65 Labeling

Label is not available on this site.

10/10/1984 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

07/21/1982 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

02/01/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

10/07/1981 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/28/1981 SUPPL-53 Labeling

Label is not available on this site.

02/18/1981 SUPPL-52 Labeling

Label is not available on this site.

06/17/1982 SUPPL-51 Labeling

Label is not available on this site.

03/02/1981 SUPPL-50 Labeling

Label is not available on this site.

03/02/1981 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

01/07/1981 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/10/1980 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/02/1980 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/08/1980 SUPPL-43 Labeling

Label is not available on this site.

10/10/1979 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/29/1979 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/22/1980 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/02/1980 SUPPL-39 Labeling

Label is not available on this site.

10/29/1979 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/27/1979 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/06/1980 SUPPL-33 Labeling

Label is not available on this site.

01/05/1979 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/01/1979 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/29/1978 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/08/1978 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/22/1978 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/11/1978 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/22/1978 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/06/1979 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/02/1978 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/15/1978 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/26/1978 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/08/1978 SUPPL-20 Labeling

Label is not available on this site.

11/22/1977 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/30/1978 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/14/1978 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/13/1978 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/1977 SUPPL-13 Labeling

Label is not available on this site.

03/15/1978 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/23/1978 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/20/1977 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/14/1978 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/27/1977 SUPPL-8 Labeling

Label is not available on this site.

04/29/1977 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/28/1976 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/08/1976 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/17/1975 SUPPL-4 Labeling

Label is not available on this site.

11/20/1975 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/03/1975 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/15/1975 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017608 ICU MEDICAL INC
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019634 B BRAUN
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 016679 BAXTER HLTHCARE

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