Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016367
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML 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
02/12/1971 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
02/23/2016 SUPPL-220 Manufacturing (CMC)

Label is not available on this site.

09/05/2013 SUPPL-218 Manufacturing (CMC)

Label is not available on this site.

10/26/2006 SUPPL-182 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016367s182ltr.pdf
09/02/2005 SUPPL-178 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016367s178ltr.pdf
11/08/2002 SUPPL-174 Manufacturing (CMC)-Control

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04/03/2002 SUPPL-173 Manufacturing (CMC)

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04/03/2002 SUPPL-172 Manufacturing (CMC)

Label is not available on this site.

03/03/2000 SUPPL-171 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/2000 SUPPL-170 Labeling

Label is not available on this site.

06/04/1999 SUPPL-169 Manufacturing (CMC)-Control

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10/29/1998 SUPPL-168 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1997 SUPPL-167 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/11/1997 SUPPL-166 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-165 Labeling

Label is not available on this site.

03/28/1997 SUPPL-164 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1996 SUPPL-163 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-162 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-161 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-160 Manufacturing (CMC)-Control

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08/27/1996 SUPPL-159 Manufacturing (CMC)-Control

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08/14/1995 SUPPL-157 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1994 SUPPL-156 Labeling

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08/30/1991 SUPPL-153 Manufacturing (CMC)-Packaging

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01/28/1992 SUPPL-152 Manufacturing (CMC)-Packaging

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09/10/1991 SUPPL-151 Manufacturing (CMC)-Control

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01/11/1990 SUPPL-149 Manufacturing (CMC)

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02/22/1990 SUPPL-148 Manufacturing (CMC)

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06/14/1989 SUPPL-147 Manufacturing (CMC)-Control

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08/08/1988 SUPPL-146 Manufacturing (CMC)

Label is not available on this site.

10/17/1988 SUPPL-145 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/30/1987 SUPPL-142 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-141 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-140 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1986 SUPPL-139 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1986 SUPPL-138 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1985 SUPPL-135 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1985 SUPPL-134 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1985 SUPPL-133 Labeling

Label is not available on this site.

09/30/1985 SUPPL-132 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/27/1985 SUPPL-130 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/26/1985 SUPPL-125 Labeling

Label is not available on this site.

05/03/1985 SUPPL-122 Manufacturing (CMC)-Control

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10/26/1985 SUPPL-121 Manufacturing (CMC)-Control

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01/18/1985 SUPPL-120 Labeling

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01/18/1985 SUPPL-119 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1984 SUPPL-116 Manufacturing (CMC)-Control

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09/26/1985 SUPPL-115 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1985 SUPPL-111 Labeling

Label is not available on this site.

11/29/1985 SUPPL-110 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1985 SUPPL-109 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1984 SUPPL-108 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1988 SUPPL-107 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1985 SUPPL-106 Labeling

Label is not available on this site.

01/08/1985 SUPPL-105 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1984 SUPPL-104 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1984 SUPPL-103 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/25/1984 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1984 SUPPL-101 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1983 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1983 SUPPL-98 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/08/1983 SUPPL-97 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1983 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1983 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

01/25/1983 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1984 SUPPL-92 Labeling

Label is not available on this site.

10/10/1984 SUPPL-91 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1982 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1983 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1982 SUPPL-86 Labeling

Label is not available on this site.

02/01/1982 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1982 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1981 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1981 SUPPL-81 Labeling

Label is not available on this site.

10/21/1981 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1981 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1981 SUPPL-78 Labeling

Label is not available on this site.

07/31/1981 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1981 SUPPL-76 Labeling

Label is not available on this site.

07/08/1982 SUPPL-75 Labeling

Label is not available on this site.

03/02/1981 SUPPL-74 Labeling

Label is not available on this site.

03/02/1981 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1981 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1980 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1981 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1980 SUPPL-68 Labeling

Label is not available on this site.

10/10/1979 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1979 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1980 SUPPL-65 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/22/1980 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1980 SUPPL-63 Labeling

Label is not available on this site.

04/16/1980 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1979 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1979 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1979 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1979 SUPPL-58 Labeling

Label is not available on this site.

02/01/1979 SUPPL-57

Label is not available on this site.

11/01/1978 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1978 SUPPL-55 Labeling

Label is not available on this site.

02/16/1979 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1978 SUPPL-53 Labeling

Label is not available on this site.

01/17/1978 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1979 SUPPL-51 Labeling

Label is not available on this site.

03/27/1979 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1978 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1978 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1979 SUPPL-47 Labeling

Label is not available on this site.

03/27/1979 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1979 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1978 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1978 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1978 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1978 SUPPL-39 Labeling

Label is not available on this site.

06/05/1978 SUPPL-38 Labeling

Label is not available on this site.

06/05/1978 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1978 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1978 SUPPL-35 Labeling

Label is not available on this site.

09/13/1978 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1978 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/17/1978 SUPPL-32 Labeling

Label is not available on this site.

06/05/1978 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1978 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/28/1977 SUPPL-27 Labeling

Label is not available on this site.

09/28/1977 SUPPL-26 Labeling

Label is not available on this site.

07/11/1978 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1977 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1977 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1977 SUPPL-21 Labeling

Label is not available on this site.

09/09/1977 SUPPL-20 Labeling

Label is not available on this site.

03/15/1978 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1977 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/15/1976 SUPPL-16 Labeling

Label is not available on this site.

11/23/1976 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1976 SUPPL-13 Labeling

Label is not available on this site.

11/08/1976 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1976 SUPPL-10 Labeling

Label is not available on this site.

04/06/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/26/2006 SUPPL-182 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf
09/02/2005 SUPPL-178 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016730 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016673 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 020179 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription No AP 207449 FRESENIUS KABI USA
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016367 ICU MEDICAL INC

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