Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017521
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 20% IN PLASTIC CONTAINER DEXTROSE 20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
DEXTROSE 30% IN PLASTIC CONTAINER DEXTROSE 30GM/100ML INJECTABLE;INJECTION Discontinued None Yes No
DEXTROSE 40% IN PLASTIC CONTAINER DEXTROSE 40GM/100ML INJECTABLE;INJECTION Discontinued None Yes No
DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE 60GM/100ML INJECTABLE;INJECTION Discontinued None Yes No
DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE;INJECTION Discontinued None Yes 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
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
03/23/2016 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

01/15/2016 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/14/2018 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017521s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017521Orig1s069ltr.pdf
12/22/2014 SUPPL-68 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
08/14/2001 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

11/14/2002 SUPPL-63 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf
11/14/2002 SUPPL-62 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf
12/07/2000 SUPPL-61 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

11/24/1999 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

05/25/1999 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/22/1998 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1997 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1993 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1995 SUPPL-50 Labeling

Label is not available on this site.

01/05/1995 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1990 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1987 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/23/1985 SUPPL-38 Labeling

Label is not available on this site.

04/15/1985 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1984 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1984 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1984 SUPPL-33 Labeling

Label is not available on this site.

02/28/1984 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1982 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1981 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-17 Labeling

Label is not available on this site.

12/21/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1982 SUPPL-15 Labeling

Label is not available on this site.

03/26/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1980 SUPPL-10 Labeling

Label is not available on this site.

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

Label is not available on this site.

07/31/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1980 SUPPL-2 Labeling

Label is not available on this site.

07/18/1980 SUPPL-1 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
03/14/2018 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017521s069lbl.pdf
12/22/2014 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf

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