Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017607
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/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
09/08/2014 SUPPL-153 Manufacturing (CMC)

Label is not available on this site.

04/10/2006 SUPPL-123 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017607s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017607Orig1s123ltr.pdf
07/18/2002 SUPPL-119 Labeling

Label is not available on this site.

03/31/1999 SUPPL-118 Labeling

Label is not available on this site.

12/01/1998 SUPPL-117 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-116 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-115 Labeling

Label is not available on this site.

03/28/1997 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-112 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-109 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

09/30/1985 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

08/27/1985 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-85 Labeling

Label is not available on this site.

05/03/1985 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 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.

06/14/1984 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.

08/31/1983 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.

06/06/1983 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-64 Labeling

Label is not available on this site.

10/10/1984 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 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.

07/08/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/01/1982 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

02/05/1982 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.

10/21/1981 SUPPL-53 Labeling

Label is not available on this site.

10/21/1981 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-51 Labeling

Label is not available on this site.

08/31/1982 SUPPL-50 Labeling

Label is not available on this site.

03/02/1981 SUPPL-49 Labeling

Label is not available on this site.

03/02/1981 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

01/07/1981 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

06/10/1980 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 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.

11/27/1979 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/17/1979 SUPPL-36 Labeling

Label is not available on this site.

01/05/1979 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/01/1979 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/07/1978 SUPPL-33 Labeling

Label is not available on this site.

11/08/1978 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/22/1978 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/11/1978 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/22/1978 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/06/1979 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/02/1978 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/15/1978 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/08/1978 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/26/1978 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/08/1978 SUPPL-21 Labeling

Label is not available on this site.

03/30/1978 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/14/1978 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/10/1978 SUPPL-18 Labeling

Label is not available on this site.

10/10/1978 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/13/1978 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/28/1977 SUPPL-15 Labeling

Label is not available on this site.

04/11/1978 SUPPL-14 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.

05/03/1977 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/29/1976 SUPPL-8 Labeling

Label is not available on this site.

06/14/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/29/1977 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/10/2006 SUPPL-123 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017607s123lbl.pdf

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017607 ICU MEDICAL INC
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 016683 BAXTER HLTHCARE

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