Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017610
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE 5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML INJECTABLE;INJECTION Prescription None No 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-119 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

07/29/1999 SUPPL-102 Labeling

Label is not available on this site.

08/06/1996 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-79 Labeling

Label is not available on this site.

05/03/1985 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

11/16/1984 SUPPL-77 Labeling

Label is not available on this site.

11/16/1984 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-69 Labeling

Label is not available on this site.

11/29/1985 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

11/28/1984 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/09/1994 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

10/25/1983 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-58 Labeling

Label is not available on this site.

10/10/1984 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

02/01/1982 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/07/1981 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-48 Labeling

Label is not available on this site.

06/14/1982 SUPPL-47 Labeling

Label is not available on this site.

10/31/1980 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-45 Labeling

Label is not available on this site.

03/02/1981 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/07/1981 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/10/1980 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

04/08/1980 SUPPL-40 Labeling

Label is not available on this site.

10/10/1979 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/29/1979 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/22/1980 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/27/1979 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.

12/03/1979 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/17/1979 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.

07/12/1978 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/08/1978 SUPPL-20 Labeling

Label is not available on this site.

03/30/1978 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/14/1978 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/28/1977 SUPPL-16 Labeling

Label is not available on this site.

03/15/1978 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/23/1978 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/20/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/11/1977 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/08/1976 SUPPL-10 Labeling

Label is not available on this site.

01/13/1977 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/14/1978 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

03/17/1976 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.

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