Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017634
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;75MG/100ML INJECTABLE;INJECTION Prescription None Yes No
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;150MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;224MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;300MG/100ML INJECTABLE;INJECTION Prescription AP 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
02/01/1979 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
07/15/2019 SUPPL-76 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017634s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017634Orig1s076ltr.pdf
05/26/2017 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017634Orig1s071s073ltr.pdf
05/26/2017 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017634Orig1s071s073ltr.pdf
09/25/2014 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

12/22/2014 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017634s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017634Orig1s069ltr.pdf
08/26/2005 SUPPL-65 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf
05/23/2005 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017634s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017634s064ltr.pdf
08/14/2001 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

01/03/2003 SUPPL-59 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17634slr059ltr.pdf
11/24/1999 SUPPL-58 Manufacturing (CMC)

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.

02/14/1992 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

02/15/1991 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1985 SUPPL-41 Labeling

Label is not available on this site.

06/13/1985 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1984 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1982 SUPPL-30 Labeling

Label is not available on this site.

04/12/1982 SUPPL-29 Labeling

Label is not available on this site.

07/11/1983 SUPPL-27 Labeling

Label is not available on this site.

11/20/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1981 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-21 Labeling

Label is not available on this site.

12/21/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1981 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1983 SUPPL-14 Labeling

Label is not available on this site.

03/01/1983 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1980 SUPPL-12 Labeling

Label is not available on this site.

06/18/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1980 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
07/15/2019 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017634s076lbl.pdf
05/26/2017 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf
05/26/2017 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf
12/22/2014 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017634s069lbl.pdf
08/26/2005 SUPPL-65 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf
05/23/2005 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017634s064lbl.pdf

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;150MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017634 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;150MG/100ML INJECTABLE;INJECTION Prescription No AP 019699 B BRAUN

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;224MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017634 BAXTER HLTHCARE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;300MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017634 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;300MG/100ML INJECTABLE;INJECTION Prescription No AP 019699 B BRAUN

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