Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016694
Company: BAXTER HLTHCARE
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
01/25/1971 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
01/15/2016 SUPPL-123 Manufacturing (CMC)

Label is not available on this site.

08/05/2019 SUPPL-121 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-120 Manufacturing (CMC)

Label is not available on this site.

12/22/2014 SUPPL-119 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-113 Labeling

Label is not available on this site.

02/04/2005 SUPPL-108 Labeling

Label is not available on this site.

05/15/2003 SUPPL-107 Labeling

Label is not available on this site.

08/29/2001 SUPPL-105 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/14/2001 SUPPL-104 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-103 Labeling

Label is not available on this site.

01/28/2000 SUPPL-102 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1999 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

05/27/1998 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

09/15/1999 SUPPL-98 Labeling

Label is not available on this site.

02/18/1994 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

03/17/1994 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

04/29/1991 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

07/30/1990 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

07/25/1987 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

05/28/1987 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

02/27/1986 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

04/10/1985 SUPPL-82 Labeling

Label is not available on this site.

06/13/1985 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

09/22/1984 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

04/13/1984 SUPPL-79 Labeling

Label is not available on this site.

02/28/1984 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

06/07/1984 SUPPL-77 Labeling

Label is not available on this site.

06/07/1984 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

08/28/1985 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

08/28/1985 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

03/16/1984 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

02/16/1982 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

07/11/1983 SUPPL-68 Labeling

Label is not available on this site.

11/20/1981 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

06/03/1982 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

11/09/1981 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

04/16/1982 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

08/26/1981 SUPPL-60 Labeling

Label is not available on this site.

12/21/1981 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/23/1982 SUPPL-58 Labeling

Label is not available on this site.

03/23/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

06/29/1981 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

01/21/1981 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/15/1980 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

12/15/1980 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/31/1980 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

04/16/1981 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

06/18/1980 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/30/1980 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/07/1980 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/18/1980 SUPPL-43 Labeling

Label is not available on this site.

03/18/1980 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/28/1980 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

08/02/1979 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/12/1978 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/20/1978 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/07/1978 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/02/1978 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/25/1978 SUPPL-34 Labeling

Label is not available on this site.

03/22/1978 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/25/1980 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/20/1978 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/24/1978 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/28/1978 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/14/1977 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

02/07/1977 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/13/1976 SUPPL-25 Labeling

Label is not available on this site.

06/17/1976 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/02/1976 SUPPL-22 Labeling

Label is not available on this site.

07/01/1976 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/05/1976 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/18/1976 SUPPL-19 Labeling

Label is not available on this site.

09/23/1975 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/11/1976 SUPPL-17 Labeling

Label is not available on this site.

09/17/1975 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/16/1975 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/10/1975 SUPPL-13 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-121 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121lbl.pdf
12/22/2014 SUPPL-119 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf

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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