Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019708
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 37MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 75MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 110MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 220MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued 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
09/29/1989 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
08/22/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/31/2005 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019630s026,019708s016ltr.pdf
09/27/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19708s013ltr.pdf
07/23/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/29/1991 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1990 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
09/27/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 150MG/100ML;900MG/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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 019708 B BRAUN
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE

POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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