Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018080
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/28/1979 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-115 Manufacturing (CMC)

Label is not available on this site.

08/07/2008 SUPPL-99 Labeling

Label is not available on this site.

04/24/2003 SUPPL-84 Labeling

Label is not available on this site.

11/01/2002 SUPPL-82 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/24/2002 SUPPL-81 Labeling

Label is not available on this site.

03/31/1999 SUPPL-80 Labeling

Label is not available on this site.

12/01/1998 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-77 Labeling

Label is not available on this site.

03/28/1997 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/25/1993 SUPPL-61 Labeling

Label is not available on this site.

10/25/1993 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/10/1985 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-50 Labeling

Label is not available on this site.

05/03/1985 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/26/1985 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/08/1984 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/11/1985 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-40 Labeling

Label is not available on this site.

11/29/1985 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/28/1984 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/06/1989 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/24/1984 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/25/1986 SUPPL-31 Labeling

Label is not available on this site.

06/25/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/08/1983 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/10/1984 SUPPL-27 Labeling

Label is not available on this site.

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

Label is not available on this site.

07/26/1982 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/01/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/08/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/07/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-17 Labeling

Label is not available on this site.

07/08/1982 SUPPL-16 Labeling

Label is not available on this site.

10/05/1981 SUPPL-15 Labeling

Label is not available on this site.

10/05/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/02/1981 SUPPL-13 Labeling

Label is not available on this site.

03/02/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/07/1981 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/11/1980 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/23/1980 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/08/1981 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/05/1980 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/08/1980 SUPPL-4 Labeling

Label is not available on this site.

12/07/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/03/1979 SUPPL-2 Labeling

Label is not available on this site.

10/10/1979 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXTROSE 10% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019626 B BRAUN
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016694 BAXTER HLTHCARE
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription No AP 209448 FRESENIUS KABI USA
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription Yes AP 018080 ICU MEDICAL INC

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