Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017606
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;225MG/100ML INJECTABLE;INJECTION Prescription None 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
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
09/05/2013 SUPPL-141 Manufacturing (CMC)

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03/21/2000 SUPPL-116 Labeling

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10/29/1998 SUPPL-115 Manufacturing (CMC)-Control

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

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08/20/1997 SUPPL-113 Labeling

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03/28/1997 SUPPL-112 Manufacturing (CMC)-Control

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08/06/1996 SUPPL-111 Manufacturing (CMC)-Control

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03/04/1996 SUPPL-110 Manufacturing (CMC)-Control

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08/18/1995 SUPPL-109 Manufacturing (CMC)

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08/29/1996 SUPPL-108 Manufacturing (CMC)-Control

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08/27/1996 SUPPL-107 Manufacturing (CMC)-Control

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08/14/1995 SUPPL-105 Manufacturing (CMC)-Control

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08/30/1991 SUPPL-102 Manufacturing (CMC)-Packaging

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01/28/1992 SUPPL-101 Manufacturing (CMC)-Packaging

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09/10/1991 SUPPL-100 Manufacturing (CMC)-Control

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01/11/1990 SUPPL-98 Manufacturing (CMC)

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02/22/1990 SUPPL-97 Manufacturing (CMC)

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07/30/1987 SUPPL-94 Manufacturing (CMC)-Control

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11/26/1986 SUPPL-93 Manufacturing (CMC)-Control

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08/08/1986 SUPPL-92 Manufacturing (CMC)-Control

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

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

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

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

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10/26/1985 SUPPL-85 Labeling

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

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10/26/1985 SUPPL-83 Manufacturing (CMC)-Control

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

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

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11/29/1985 SUPPL-77 Labeling

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

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

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

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

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

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06/14/1984 SUPPL-71 Manufacturing (CMC)-Expiration Date

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

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

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08/31/1983 SUPPL-68 Manufacturing (CMC)-Control

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

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

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

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10/10/1984 SUPPL-64 Labeling

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

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07/26/1982 SUPPL-62 Manufacturing (CMC)-Control

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

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

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

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

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02/05/1982 SUPPL-57 Manufacturing (CMC)-Control

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

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

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

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10/21/1981 SUPPL-53 Labeling

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

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03/02/1981 SUPPL-51 Labeling

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08/31/1982 SUPPL-50 Labeling

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03/02/1981 SUPPL-49 Labeling

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

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

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

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

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02/12/1980 SUPPL-44 Manufacturing (CMC)-Control

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04/08/1980 SUPPL-43 Labeling

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

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

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

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

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

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

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07/17/1979 SUPPL-36 Labeling

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

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02/01/1979 SUPPL-34

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11/07/1978 SUPPL-33 Labeling

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

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

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

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

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

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

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

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

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

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02/08/1978 SUPPL-21 Labeling

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

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

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10/10/1978 SUPPL-18 Labeling

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

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

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09/28/1977 SUPPL-15 Labeling

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04/11/1978 SUPPL-14 Manufacturing (CMC)-Control

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

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

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05/09/1977 SUPPL-9 Manufacturing (CMC)-Control

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12/03/1976 SUPPL-8 Labeling

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

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04/29/1977 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

10/22/1975 SUPPL-4 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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