Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017586
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORMOSOL-R IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/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
03/22/2016 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

09/05/2013 SUPPL-127 Manufacturing (CMC)

Label is not available on this site.

06/15/2000 SUPPL-107 Labeling

Label is not available on this site.

10/29/1998 SUPPL-106 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1998 SUPPL-105 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

05/12/1998 SUPPL-103 Labeling

Label is not available on this site.

08/06/1996 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-101 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1996 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1991 SUPPL-96 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-95 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-94 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1986 SUPPL-85 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/31/1986 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

05/14/1985 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-78 Labeling

Label is not available on this site.

05/03/1985 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1984 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

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)-Control

Label is not available on this site.

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

Label is not available on this site.

06/22/1989 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1984 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1983 SUPPL-64 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/17/1984 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1983 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1984 SUPPL-60 Labeling

Label is not available on this site.

01/17/1984 SUPPL-59 Manufacturing (CMC)-Formulation

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)-Packaging

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

06/18/1982 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1982 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1982 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1981 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1981 SUPPL-47 Labeling

Label is not available on this site.

07/08/1982 SUPPL-46 Labeling

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)-Control

Label is not available on this site.

09/11/1980 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1981 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1980 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1980 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1980 SUPPL-39 Labeling

Label is not available on this site.

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

Label is not available on this site.

11/29/1979 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1980 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1979 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

12/03/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1979 SUPPL-32 Labeling

Label is not available on this site.

01/05/1979 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1979 SUPPL-30

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

07/12/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1978 SUPPL-19 Labeling

Label is not available on this site.

03/09/1978 SUPPL-18 Labeling

Label is not available on this site.

03/09/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

09/28/1977 SUPPL-13 Labeling

Label is not available on this site.

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

Label is not available on this site.

01/23/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1977 SUPPL-8 Labeling

Label is not available on this site.

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

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)-Packaging

Label is not available on this site.

10/21/1975 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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English