Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018090
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription AP 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
04/04/1979 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
09/21/2017 SUPPL-116 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018090sS116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018090Orig1s116ltr.pdf
09/08/2014 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

09/17/2014 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

04/16/2007 SUPPL-87 Labeling

Label is not available on this site.

04/16/2017 SUPPL-86

Label is not available on this site.

11/01/2002 SUPPL-81 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/2001 SUPPL-80 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/01/1998 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

09/21/1998 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-75 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/018090s075lbl.pdf
08/06/1996 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

05/19/1994 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

10/25/1993 SUPPL-62 Labeling

Label is not available on this site.

10/25/1993 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/16/1988 SUPPL-58 Labeling

Label is not available on this site.

02/16/1988 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-47 Labeling

Label is not available on this site.

05/03/1985 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-39 Labeling

Label is not available on this site.

11/29/1985 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/06/1989 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/25/1983 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-29 Labeling

Label is not available on this site.

10/10/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/01/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/07/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-19 Labeling

Label is not available on this site.

08/31/1982 SUPPL-18 Labeling

Label is not available on this site.

03/02/1981 SUPPL-17 Labeling

Label is not available on this site.

03/02/1981 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/07/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/24/1980 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/10/1980 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/28/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/05/1980 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/08/1980 SUPPL-9 Labeling

Label is not available on this site.

10/10/1979 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/29/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/09/1979 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/19/1979 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/22/1980 SUPPL-4 Labeling

Label is not available on this site.

07/06/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/07/1979 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/07/1979 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
09/21/2017 SUPPL-116 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018090sS116lbl.pdf
07/02/1999 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/018090s075lbl.pdf

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019635 B BRAUN
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription No AP 018016 BAXTER HLTHCARE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription No AP 208122 FRESENIUS KABI USA
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription No AP 019759 HOSPIRA
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018090 ICU MEDICAL INC

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