Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018251
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/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
05/16/1980 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-89 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-70 Labeling

Label is not available on this site.

12/01/1998 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

10/12/1999 SUPPL-66 Labeling

Label is not available on this site.

08/06/1996 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-42 Labeling

Label is not available on this site.

05/03/1985 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/09/1984 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-33 Labeling

Label is not available on this site.

11/29/1985 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/22/1989 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/25/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-23 Labeling

Label is not available on this site.

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

Label is not available on this site.

07/26/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

07/08/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/07/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-13 Labeling

Label is not available on this site.

06/17/1982 SUPPL-12 Labeling

Label is not available on this site.

09/30/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-10 Labeling

Label is not available on this site.

03/02/1981 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/03/1980 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/07/1981 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/10/1980 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/10/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/08/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/10/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/11/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 33MG/100ML;30MG/100ML;860MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML INJECTABLE;INJECTION Prescription No AP 020002 B BRAUN
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML INJECTABLE;INJECTION Prescription No AP 016693 BAXTER HLTHCARE
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML INJECTABLE;INJECTION Prescription No AP 018251 ICU MEDICAL INC

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