Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016673
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
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
03/04/1971 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
07/14/2016 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

01/15/2016 SUPPL-151 Manufacturing (CMC)

Label is not available on this site.

09/16/2015 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

08/05/2019 SUPPL-149 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016673Orig1s149, 016694Orig1s121, 020047Orig1s021, 020179Orig1s012ltr.pdf
05/23/2014 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

12/22/2014 SUPPL-147 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf
07/10/2006 SUPPL-140 Labeling

Label is not available on this site.

02/04/2005 SUPPL-135 Labeling

Label is not available on this site.

05/15/2003 SUPPL-129 Labeling

Label is not available on this site.

08/29/2001 SUPPL-127 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/28/2000 SUPPL-126 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/29/1997 SUPPL-125 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

06/10/1997 SUPPL-123 Manufacturing (CMC)

Label is not available on this site.

09/15/1999 SUPPL-122 Labeling

Label is not available on this site.

10/11/1996 SUPPL-121 Manufacturing (CMC)

Label is not available on this site.

11/14/1996 SUPPL-120 Manufacturing (CMC)

Label is not available on this site.

09/27/1995 SUPPL-119 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-117 Manufacturing (CMC)

Label is not available on this site.

01/06/1993 SUPPL-116 Manufacturing (CMC)

Label is not available on this site.

06/01/1993 SUPPL-112 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

07/30/1990 SUPPL-109 Manufacturing (CMC)

Label is not available on this site.

03/23/1990 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

06/14/1988 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

01/10/1989 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

04/27/1987 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

07/25/1987 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

05/28/1987 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

02/27/1986 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

04/15/1985 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

04/15/1985 SUPPL-95 Labeling

Label is not available on this site.

06/13/1985 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

09/22/1984 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

10/30/1985 SUPPL-90 Labeling

Label is not available on this site.

10/30/1985 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

09/21/1984 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

02/28/1984 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

08/28/1985 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

08/28/1985 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

03/16/1984 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

04/08/1982 SUPPL-78 Labeling

Label is not available on this site.

05/20/1981 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

02/16/1982 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

07/11/1983 SUPPL-75 Labeling

Label is not available on this site.

11/20/1981 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

06/03/1982 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

11/09/1981 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

04/16/1982 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

08/26/1981 SUPPL-69 Labeling

Label is not available on this site.

12/21/1981 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

04/23/1981 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

06/29/1981 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

01/21/1981 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

07/31/1980 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

08/06/1981 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

04/16/1981 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/18/1980 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/30/1980 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

05/27/1980 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

02/22/1980 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

08/07/1980 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/28/1980 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

08/02/1979 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/23/1979 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/12/1978 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/08/1978 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/20/1978 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/07/1978 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/02/1978 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/25/1978 SUPPL-43 Labeling

Label is not available on this site.

03/22/1978 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/25/1980 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/20/1978 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/24/1978 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

02/28/1978 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/14/1977 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/06/1977 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/07/1977 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/11/1978 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/11/1978 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/11/1977 SUPPL-32 Labeling

Label is not available on this site.

07/13/1976 SUPPL-30 Labeling

Label is not available on this site.

01/11/1978 SUPPL-28 Labeling

Label is not available on this site.

01/11/1978 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/17/1976 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/02/1976 SUPPL-24 Labeling

Label is not available on this site.

07/01/1976 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/05/1976 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/12/1976 SUPPL-20 Labeling

Label is not available on this site.

07/30/1975 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/11/1976 SUPPL-18 Labeling

Label is not available on this site.

09/17/1975 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/16/1975 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/10/1975 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/05/2019 SUPPL-149 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121lbl.pdf
12/22/2014 SUPPL-147 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML
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 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016730 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019626 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016673 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 020179 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019466 HOSPIRA
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019479 HOSPIRA

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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