Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017514
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 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
04/08/1974 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-69 Manufacturing (CMC)

Label is not available on this site.

04/21/2004 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17514slr058ltr.pdf
02/10/1998 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

06/30/1992 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/24/1993 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/25/1988 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

11/12/1986 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

01/18/1986 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

08/25/1984 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/10/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/06/1981 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/05/1981 SUPPL-40 Labeling

Label is not available on this site.

08/31/1982 SUPPL-39 Labeling

Label is not available on this site.

09/25/1980 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/09/1980 SUPPL-37 Labeling

Label is not available on this site.

06/06/1980 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/06/1980 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/28/1980 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/21/1981 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/20/1980 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/31/1979 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/05/1979 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/17/1979 SUPPL-23 Labeling

Label is not available on this site.

01/03/1979 SUPPL-22 Labeling

Label is not available on this site.

05/01/1979 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/01/1978 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/22/1978 SUPPL-19 Labeling

Label is not available on this site.

11/22/1978 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/16/1978 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/12/1978 SUPPL-16 Labeling

Label is not available on this site.

07/12/1978 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/27/1977 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/31/1977 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/20/1976 SUPPL-12 Labeling

Label is not available on this site.

03/29/1976 SUPPL-11 Labeling

Label is not available on this site.

10/07/1975 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/15/1975 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/04/1975 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/15/1975 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 900MG/100ML
TE Code = AT

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 SOLUTION;IRRIGATION Prescription Yes AT 016733 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML SOLUTION;IRRIGATION Prescription No AT 017427 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML SOLUTION;IRRIGATION Prescription No AT 017867 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML SOLUTION;IRRIGATION Prescription No AT 017514 ICU MEDICAL INC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML SOLUTION;IRRIGATION Prescription No AT 018314 ICU MEDICAL INC

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