Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019367
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription None No No
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription None No No
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/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
04/05/1985 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
09/30/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/06/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019367s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019367s030ltr.pdf
04/26/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/19/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf
08/26/2005 SUPPL-22 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
06/07/2005 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019367s021ltr.pdf
08/14/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/03/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19367slr015ltr.pdf
11/24/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1991 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-2 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
12/06/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019367s030lbl.pdf
10/19/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf
08/26/2005 SUPPL-22 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf
06/07/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019685 ICU MEDICAL INC

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019367 BAXTER HLTHCARE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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