Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017637
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHYSIOSOL IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML SOLUTION;IRRIGATION Prescription None 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
02/08/1978 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-61 Manufacturing (CMC)

Label is not available on this site.

06/04/1999 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/2000 SUPPL-46 Labeling

Label is not available on this site.

02/04/1998 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/12/1998 SUPPL-44 Labeling

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.

11/25/1988 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.

03/15/1984 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1982 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1982 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1982 SUPPL-25 Labeling

Label is not available on this site.

10/01/1980 SUPPL-24 Labeling

Label is not available on this site.

09/08/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1980 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1980 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1979 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/1979 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1979 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1978 SUPPL-7 Labeling

Label is not available on this site.

11/22/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1978 SUPPL-5 Labeling

Label is not available on this site.

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

Label is not available on this site.

06/30/1978 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1978 SUPPL-2 Labeling

Label is not available on this site.

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