Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017641
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP 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
01/26/1976 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
06/14/2016 SUPPL-163 Manufacturing (CMC)

Label is not available on this site.

09/08/2014 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

09/17/2014 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

04/10/2006 SUPPL-131 Labeling

Label is not available on this site.

10/28/1999 SUPPL-124 Labeling

Label is not available on this site.

12/01/1998 SUPPL-123 Manufacturing (CMC)

Label is not available on this site.

08/21/1997 SUPPL-122 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-121 Manufacturing (CMC)

Label is not available on this site.

10/13/1999 SUPPL-120 Labeling

Label is not available on this site.

03/28/1997 SUPPL-119 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-117 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-116 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-109 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

08/27/1985 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-89 Labeling

Label is not available on this site.

05/03/1985 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

11/09/1984 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-80 Labeling

Label is not available on this site.

11/29/1985 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

06/22/1989 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

03/15/1985 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

08/31/1983 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-67 Labeling

Label is not available on this site.

10/10/1984 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

07/21/1982 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/01/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/05/1982 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

10/07/1981 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

10/21/1981 SUPPL-54 Labeling

Label is not available on this site.

10/21/1981 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-52 Labeling

Label is not available on this site.

06/17/1982 SUPPL-51 Labeling

Label is not available on this site.

03/02/1981 SUPPL-50 Labeling

Label is not available on this site.

03/02/1981 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

09/03/1980 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

05/28/1980 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

04/08/1980 SUPPL-43 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

09/04/1979 SUPPL-35 Labeling

Label is not available on this site.

02/01/1979 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/07/1978 SUPPL-33 Labeling

Label is not available on this site.

02/22/1979 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

02/08/1978 SUPPL-22 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

10/10/1978 SUPPL-18 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

10/19/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/1977 SUPPL-14 Labeling

Label is not available on this site.

03/15/1978 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

11/24/1976 SUPPL-9 Labeling

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.

05/06/1976 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/01/1976 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/04/1976 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/10/1976 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/25/1976 SUPPL-2 Labeling

Label is not available on this site.

02/25/1976 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019632 B BRAUN
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016682 BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 017641 ICU MEDICAL INC

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