Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018008
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None No No
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None No No
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;450MG/100ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription None No 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
02/02/1979 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
02/21/2019 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018008Orig1s073,018037Orig1s073,018629Orig1s046,019308Orig1s030ltr.pdf
09/26/2014 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

09/10/2013 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf
04/20/2007 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.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
06/02/2004 SUPPL-63 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf
08/14/2001 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

04/14/2003 SUPPL-59 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.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.

04/22/1993 SUPPL-54 Labeling

Label is not available on this site.

12/11/1991 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 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-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1985 SUPPL-42 Labeling

Label is not available on this site.

06/13/1985 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1984 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1982 SUPPL-32 Labeling

Label is not available on this site.

04/28/1982 SUPPL-31 Labeling

Label is not available on this site.

07/11/1983 SUPPL-29 Labeling

Label is not available on this site.

11/20/1981 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-23 Labeling

Label is not available on this site.

12/21/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1980 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.

08/02/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1979 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
02/21/2019 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf
09/10/2013 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf
04/20/2007 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.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

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE

INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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