Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017635
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 SOLUTION;IRRIGATION Prescription AT 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
05/14/1976 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
06/12/2014 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2000 SUPPL-45 Labeling

Label is not available on this site.

02/04/1998 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1996 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1992 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1993 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/27/1988 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

01/18/1986 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1984 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

03/15/1984 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1982 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1982 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1982 SUPPL-24 Labeling

Label is not available on this site.

09/30/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1980 SUPPL-22 Labeling

Label is not available on this site.

06/06/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1980 SUPPL-16 Labeling

Label is not available on this site.

07/21/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1980 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1979 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1979 SUPPL-6 Labeling

Label is not available on this site.

05/01/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1977 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/28/1976 SUPPL-1 Labeling

Label is not available on this site.

RINGER'S IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 33MG/100ML;30MG/100ML;860MG/100ML
TE Code = AT

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 SOLUTION;IRRIGATION Prescription No AT 018156 B BRAUN
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION;IRRIGATION Prescription No AT 018495 BAXTER HLTHCARE
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION;IRRIGATION Prescription No AT 017635 ICU MEDICAL INC

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