Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016366
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/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
02/24/1972 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
04/27/2016 SUPPL-215 Manufacturing (CMC)

Label is not available on this site.

09/21/2017 SUPPL-214 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016366s214lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016366Orig1s214ltr.pdf
09/08/2014 SUPPL-212 Manufacturing (CMC)

Label is not available on this site.

09/17/2014 SUPPL-201 Manufacturing (CMC)

Label is not available on this site.

04/16/2007 SUPPL-174 Labeling

Label is not available on this site.

04/10/2006 SUPPL-167 Labeling

Label is not available on this site.

11/01/2002 SUPPL-161 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/03/2000 SUPPL-160 Labeling

Label is not available on this site.

05/03/2000 SUPPL-159 Manufacturing (CMC)-Facility

Label is not available on this site.

12/01/1998 SUPPL-157 Manufacturing (CMC)

Label is not available on this site.

08/21/1997 SUPPL-156 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-154 Manufacturing (CMC)

Label is not available on this site.

06/25/1999 SUPPL-153 Labeling

Label is not available on this site.

03/28/1997 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-151 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

03/29/1996 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

03/29/1996 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-146 Manufacturing (CMC)

Label is not available on this site.

05/24/1994 SUPPL-145 Labeling

Label is not available on this site.

08/30/1991 SUPPL-142 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-141 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-138 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

06/14/1989 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

10/17/1988 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

06/07/1988 SUPPL-134 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-131 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

06/24/1986 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

01/18/1986 SUPPL-128 Manufacturing (CMC)

Label is not available on this site.

02/22/1986 SUPPL-127 Manufacturing (CMC)

Label is not available on this site.

06/21/1985 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-123 Manufacturing (CMC)

Label is not available on this site.

11/07/1985 SUPPL-122 Labeling

Label is not available on this site.

01/31/1986 SUPPL-120 Manufacturing (CMC)

Label is not available on this site.

08/27/1985 SUPPL-119 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-114 Labeling

Label is not available on this site.

05/03/1985 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

01/18/1985 SUPPL-109 Labeling

Label is not available on this site.

01/18/1985 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

04/23/1985 SUPPL-102 Labeling

Label is not available on this site.

04/23/1985 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-100 Labeling

Label is not available on this site.

11/29/1985 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

08/06/1986 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

01/08/1985 SUPPL-95 Labeling

Label is not available on this site.

01/08/1985 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

09/25/1984 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

08/31/1983 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

01/17/1983 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

09/19/1983 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

01/25/1983 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-82 Labeling

Label is not available on this site.

10/10/1984 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

05/26/1982 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

02/22/1982 SUPPL-76 Labeling

Label is not available on this site.

02/01/1982 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

08/25/1981 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

10/21/1981 SUPPL-71 Labeling

Label is not available on this site.

10/21/1981 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

09/16/1981 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

07/31/1981 SUPPL-68 Labeling

Label is not available on this site.

07/31/1981 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-66 Labeling

Label is not available on this site.

08/31/1982 SUPPL-65 Labeling

Label is not available on this site.

03/02/1981 SUPPL-64 Labeling

Label is not available on this site.

03/02/1981 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

01/07/1981 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

07/16/1981 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/10/1980 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/28/1980 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/08/1980 SUPPL-55 Labeling

Label is not available on this site.

10/10/1979 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

11/29/1979 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

01/21/1980 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/16/1980 SUPPL-51 Labeling

Label is not available on this site.

04/16/1980 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

11/27/1979 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

07/17/1979 SUPPL-46 Labeling

Label is not available on this site.

01/05/1979 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/01/1979 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/16/1979 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

10/25/1978 SUPPL-42 Labeling

Label is not available on this site.

10/25/1978 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/27/1979 SUPPL-40 Labeling

Label is not available on this site.

03/27/1979 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/08/1978 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/27/1978 SUPPL-37 Labeling

Label is not available on this site.

10/27/1978 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/20/1978 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/27/1979 SUPPL-34 Labeling

Label is not available on this site.

03/27/1979 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/06/1979 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/03/1978 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/15/1978 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/08/1978 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/26/1978 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/06/1978 SUPPL-26 Labeling

Label is not available on this site.

02/08/1978 SUPPL-25 Labeling

Label is not available on this site.

06/02/1978 SUPPL-24 Labeling

Label is not available on this site.

06/02/1978 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/05/1978 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/31/1978 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/13/1978 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/28/1977 SUPPL-17 Labeling

Label is not available on this site.

03/15/1978 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/23/1978 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/15/1977 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/15/1977 SUPPL-13 Labeling

Label is not available on this site.

06/08/1978 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/29/1977 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/08/1976 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/20/1975 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/03/1975 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/29/1975 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/19/1975 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/07/1975 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/19/1975 SUPPL-2 Labeling

Label is not available on this site.

03/02/1976 SUPPL-1 Labeling

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-214 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016366s214lbl.pdf

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 900MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017464 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019635 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016677 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 020178 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 207310 FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 078177 FRESENIUS MEDCL
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 076316 HAEMONETICS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019465 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019480 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016366 ICU MEDICAL INC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 207956 LABORATORIOS GRIFOLS

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